InfertilityPhase 3PRESCORINCT02884245
Interest of Estrogen Scheduling Before Ovarian Stimulation With Corifollitropin Alfa
A Phase 3 study testing Estrogens in people with Infertility, run by Centre Hospitalier Intercommunal Creteil at 3 sites in France.
Trial summary
E2 given in late luteal phase can be extended beyond the onset of menses for a period of at least eight days before the start of the stimulation, allowing scheduling of stimulation in order to limit oocytes retrievals during weekends . Read more about this study
- Who is it for?
- Ages 38 to 47 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Estrogens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 3 sitesFrance
- Study dates
- 4 Nov 2016to 4 Jan 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 47 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient of 38 years or more
- Planned in invitro fertilization or intracytoplasmic sperm injection rank 1 or 2 (rank = retrieval with transfer)
- With regular cycles from 26 to 35 days
- Weight > 50 kg and body mass index< or equal to 32
- Affiliation to the general system of French social security and reimbursement for fertility problems
Who cannot join
- Irregular cycles and/or polycystic ovarian syndrome
- Previous History of ovarian hyperstimulation syndrome
- Rank puncture > 2
- Uterine malformation
- Presence of hydrosalpinges
- Endometriosis stage III or IV
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Jean Verdier
Bondy, 93140
CHI Creteil
Créteil, 94000
Clinique de la Sagesse
Rennes, 35043
About this study
Official title: Interest of Estrogen Scheduling Before Ovarian Stimulation With Corifollitropin Alfa in Women Older Than 38 Years Old Undergoing in Vitro Fertilization
E2 given in late luteal phase can be extended beyond the onset of menses for a period of at least eight days before the start of the stimulation, allowing scheduling of stimulation in order to limit oocytes retrievals during weekends .
Administration of corifollitropin alfa, a Follicule stimulating Hormone (FSH) with extended release kinetics, seems particularly interesting for a synchronous recruitment of follicles after homogenization of the cohort.
Read more
The objective of this study is to evaluate the impact on the response to ovarian stimulation with corifollitropin alfa of E2 scheduling versus no scheduling for women over 38 years, age at which declining of ovarian reserve usually begins. The management of these patients in terms of organization of the center is also evaluated.
The scheduling of IVF cycles represents a double benefit. On one hand, to enable a "synchronization" of the follicular cohort for a best response and a higher number of mature oocytes. On the other hand, a more efficient organization for both the center (avoiding retrievals on weekends and public holidays, organize and distribute equally the activity, reduce cost operations) and couples (personal and professional organization).
Read the detailed description
With advanced age, ovarian reserve decreases, follicular cohort becomes heterogeneous under the influence of higher FSH rise in late luteal phase. It has been shown that estrogens (E2) taken in the late luteal phase homogenized follicular cohort by inhibiting inter cycle FSH peak ,and that this inhibition is immediately reversible after discontinuation of treatment .
E2 given in late luteal phase can also be extended beyond the onset of menses for a period of at least eight days before the start of the stimulation, allowing scheduling of stimulation in order to limit oocytes retrievals during weekends . A prospective randomized study comparing E2 scheduling and no scheduling has shown that there was no difference in birth rate in a population of normo-responders women . While in these patients, the number of oocytes was not different in the two arms, a recent pilot study founded a significant increase in the number of oocytes retrieved after E2 luteal phase priming compared to the absence of priming in a population of poor responders .
In 2013, a report of the French governmental BioMedicine Agency warned about the thrombo-embolic risk associated with the use of the contraceptive pill for IVF scheduling, especially in women over 35.
Administration of corifollitropin alfa, an FSH with extended release kinetics, seems particularly interesting for a synchronous recruitment of follicles after homogenization of the cohort. In the Pursue study, an equivalent efficacy has been shown with the daily administration of 300 IU FSH and corifollitropin alfa in patients over 35 years .
The objective of this study is to evaluate the impact of the response to ovarian stimulation with corifollitropin alfa of E2 scheduling versus no scheduling for women over 38 years, age at which declining of ovarian reserve usually begins. The management of these patients in terms of organization of the center is also evaluated.
The scheduling of IVF cycles represents a double benefit. On one hand, to enable a "synchronization" of the follicular cohort for a best response and a higher number of mature oocytes. On the other hand, a more efficient organization for both the center (avoiding retrievals on weekends and public holidays, organize and distribute equally the activity, reduce cost operations) and couples (personal and professional organization). This can be done with pills but there are controversial data on its impact on the chances of birth. It has been shown that estrogen scheduling provides opportunities for success equivalent to the absence of scheduling for patients with good prognosis . If this study confirms the initial hypothesis, it will show that a less favorable public can profit from the benefits of scheduling by estrogen on both the organization of the attempt and the chances of pregnancy through better ovarian response.
- Conditions
- Infertility
- Being tested
- Estrogens
- Keywords
- Fertility, Reproductive processes, In vitro fertilization, Intracytoplasmic sperm injection, Estrogens, Follicule Stimulating Hormon
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstrogensDrug
The estrogens pretreatment will began between the day 20 and the day 24 of an ovarian cycle and should be continued until Wednesday beyond the onset of menses
| Study group | Role | What they receive |
|---|---|---|
| Arm E2: With estrogens pretreatment | Experimental | The estrogens pretreatment will began between the day 20 and the day 24 of an ovarian cycle and should be continued until Wednesday beyond the onset of menses Receives: Drug: Estrogens |
| Arm S: without estrogens pretreatment | No intervention | No estrogen pretreatment will be delivered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of selected oocytes
Measured: At time of ovarian puncture
Secondary outcomes (14)
Number of days of pretreatment
Measured: From inclusion visit date to the beginning of stimulation, up to 15 days
Cancellation rate
Measured: From date of inclusion visit until the date of embryo transfer, up to 90 days
Number of days of antagonist
Measured: From date of stimulation until the date of the trigger, up to 30 days
The day of the trigger
Measured: At time of the trigger
Estradiol rate
Measured: 8 days from the beginning of stimulation and the day of the trigger
Luteinizing hormone rate
Measured: 8 days from the beginning of stimulation and the day of the trigger
Progesterone rate
Measured: 8 days from the beginning of stimulation and the day of the trigger
Follicles number > 10 mm
Measured: 8 days from the beginning of stimulation
Follicles number > 14 mm
Measured: From 1 day before the day of trigger or the day of trigger
Number of oocytes in metaphase 2
Measured: At time of ovarian puncture
Total number of embryos with good quality
Measured: At time of fertilization procedure
early pregnancy
Beta Human chorionic gonadotropin>100 U/l
Measured: 14 days after embryo transfer
ongoing pregnancy rate
on ultrasound procedure
Measured: 12 weeks after embryo transfer
miscarriage before 12 weeks of amenorrhea
Measured: From embryo transfer to 12 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start4 Nov 2016
- Primary completion1 Jul 2022
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Anne GUIVARC'H-LEVEQUE, Centre Hospitalier Intercommunal Creteil
- Investigators
- Anne GUIVARC'H - LEVEQUE, MD, Principal investigator, Clinique de la SagesseIsabelle CEDRIN - DURNERIN, MD, Principal investigator, CHU Jean Verdier - APHPNathalie MASSIN, MD, Principal investigator, CHI Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884245
- Sponsor's protocol ID
- PRESCORI
- Acronym
- PRESCORI
- Status last verified
- Feb 2023
- First submitted
- 22 Aug 2016
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Blockeel C, Engels S, De Vos M, Haentjens P, Polyzos NP, Stoop D, Camus M, Devroey P. Oestradiol valerate pretreatment in GnRH-antagonist cycles: a randomized controlled trial. Reprod Biomed Online. 2012 Mar;24(3):272-80. doi: 10.1016/j.rbmo.2011.11.012. Epub 2011 Nov 30.
PubMed 22296973Boostanfar R, Shapiro B, Levy M, Rosenwaks Z, Witjes H, Stegmann BJ, Elbers J, Gordon K, Mannaerts B; Pursue investigators. Large, comparative, randomized double-blind trial confirming noninferiority of pregnancy rates for corifollitropin alfa compared with recombinant follicle-stimulating hormone in a gonadotropin-releasing hormone antagonist controlled ovarian stimulation protocol in older patients undergoing in vitro fertilization. Fertil Steril. 2015 Jul;104(1):94-103.e1. doi: 10.1016/j.fertnstert.2015.04.018. Epub 2015 May 21.
PubMed 26003273Cedrin-Durnerin I, Bstandig B, Parneix I, Bied-Damon V, Avril C, Decanter C, Hugues JN. Effects of oral contraceptive, synthetic progestogen or natural estrogen pre-treatments on the hormonal profile and the antral follicle cohort before GnRH antagonist protocol. Hum Reprod. 2007 Jan;22(1):109-16. doi: 10.1093/humrep/del340. Epub 2006 Aug 26.
PubMed 16936304Cedrin-Durnerin I, Guivarc'h-Leveque A, Hugues JN; Groupe d'Etude en Medecine et Endocrinologie de la Reproduction. Pretreatment with estrogen does not affect IVF-ICSI cycle outcome compared with no pretreatment in GnRH antagonist protocol: a prospective randomized trial. Fertil Steril. 2012 Jun;97(6):1359-64.e1. doi: 10.1016/j.fertnstert.2012.02.028. Epub 2012 Mar 28.
PubMed 22464760Chang X, Wu J. Effects of luteal estradiol pre-treatment on the outcome of IVF in poor ovarian responders. Gynecol Endocrinol. 2013 Mar;29(3):196-200. doi: 10.3109/09513590.2012.736558. Epub 2012 Nov 30.
PubMed 23194136Escriva AM, Diaz-Garcia C, Monterde M, Rubio JM, Pellicer A. Antral Follicle Priming Before Intracytoplasmic Sperm Injection in Previously Diagnosed Low Responders: A Randomized Controlled Trial (FOLLPRIM). J Clin Endocrinol Metab. 2015 Jul;100(7):2597-605. doi: 10.1210/jc.2015-1194. Epub 2015 May 8.
PubMed 25955224Fanchin R, Salomon L, Castelo-Branco A, Olivennes F, Frydman N, Frydman R. Luteal estradiol pre-treatment coordinates follicular growth during controlled ovarian hyperstimulation with GnRH antagonists. Hum Reprod. 2003 Dec;18(12):2698-703. doi: 10.1093/humrep/deg516.
PubMed 14645194Guivarc'h-Leveque A, Homer L, Arvis P, Broux PL, Moy L, Priou G, Vialard J, Colleu D, Dewailly D. Programming in vitro fertilization retrievals during working days after a gonadotropin-releasing hormone antagonist protocol with estrogen pretreatment: does the length of exposure to estradiol impact on controlled ovarian hyperstimulation outcomes? Fertil Steril. 2011 Oct;96(4):872-6. doi: 10.1016/j.fertnstert.2011.07.1138. Epub 2011 Aug 24.
PubMed 21868004Hauzman EE, Zapata A, Bermejo A, Iglesias C, Pellicer A, Garcia-Velasco JA. Cycle scheduling for in vitro fertilization with oral contraceptive pills versus oral estradiol valerate: a randomized, controlled trial. Reprod Biol Endocrinol. 2013 Sep 28;11:96. doi: 10.1186/1477-7827-11-96.
PubMed 24074027Nielsen AP, Korsholm AS, Lemmen JG, Sylvest R, Sopa N, Nyboe Andersen A. Selective use of corifollitropin for controlled ovarian stimulation for IVF in patients with low anti-Mullerian hormone. Gynecol Endocrinol. 2016 Aug;32(8):625-628. doi: 10.3109/09513590.2016.1147548. Epub 2016 Feb 18.
PubMed 26891977Polyzos NP, De Vos M, Corona R, Vloeberghs V, Ortega-Hrepich C, Stoop D, Tournaye H. Addition of highly purified HMG after corifollitropin alfa in antagonist-treated poor ovarian responders: a pilot study. Hum Reprod. 2013 May;28(5):1254-60. doi: 10.1093/humrep/det045. Epub 2013 Feb 26.
PubMed 23442756Reynolds KA, Omurtag KR, Jimenez PT, Rhee JS, Tuuli MG, Jungheim ES. Cycle cancellation and pregnancy after luteal estradiol priming in women defined as poor responders: a systematic review and meta-analysis. Hum Reprod. 2013 Nov;28(11):2981-9. doi: 10.1093/humrep/det306. Epub 2013 Jul 25.
PubMed 23887073Cedrin-Durnerin I, Carton I, Massin N, Chevalier N, Dubourdieu S, Bstandig B, Michelson X, Goro S, Jung C, Guivarc'h-Leveque A. Pretreatment with luteal estradiol for programming antagonist cycles compared to no pretreatment in advanced age women stimulated with corifollitropin alfa: a non-inferiority randomized controlled trial. Hum Reprod. 2024 Sep 1;39(9):1979-1986. doi: 10.1093/humrep/deae167.
PubMed 39008826
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Estrogen Scheduling Before Ovarian Stimulation With Corifollitropin Alfa in Women Older Than 38 Years Old Undergoing in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT02884245
- Acronym / sponsor ID
- PRESCORI / PRESCORI
- Conditions
- Infertility
- Keywords
- Fertility, Reproductive processes, In vitro fertilization, Intracytoplasmic sperm injection, Estrogens, Follicule Stimulating Hormon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 4 Nov 2016 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
E2 given in late luteal phase can be extended beyond the onset of menses for a period of at least eight days before the start of the stimulation, allowing scheduling of stimulation in order to limit oocytes retrievals during weekends .
Administration of corifollitropin alfa, a Follicule stimulating Hormone (FSH) with extended release kinetics, seems particularly interesting for a synchronous recruitment of follicles after homogenization of the cohort.
The objective of this study is to evaluate the impact on the response to ovarian stimulation with corifollitropin alfa of E2 scheduling versus no scheduling for women over 38 years, age at which declining of ovarian reserve usually begins. The management of these patients in terms of organization of the center is also evaluated.
The scheduling of IVF cycles represents a double benefit. On one hand, to enable a "synchronization" of the follicular cohort for a best response and a higher number of mature oocytes. On the other hand, a more efficient organization for both the center (avoiding retrievals on weekends and public holidays, organize and distribute equally the activity, reduce cost operations) and couples (personal and professional organization).
Detailed description
With advanced age, ovarian reserve decreases, follicular cohort becomes heterogeneous under the influence of higher FSH rise in late luteal phase. It has been shown that estrogens (E2) taken in the late luteal phase homogenized follicular cohort by inhibiting inter cycle FSH peak ,and that this inhibition is immediately reversible after discontinuation of treatment .
E2 given in late luteal phase can also be extended beyond the onset of menses for a period of at least eight days before the start of the stimulation, allowing scheduling of stimulation in order to limit oocytes retrievals during weekends . A prospective randomized study comparing E2 scheduling and no scheduling has shown that there was no difference in birth rate in a population of normo-responders women . While in these patients, the number of oocytes was not different in the two arms, a recent pilot study founded a significant increase in the number of oocytes retrieved after E2 luteal phase priming compared to the absence of priming in a population of poor responders .
In 2013, a report of the French governmental BioMedicine Agency warned about the thrombo-embolic risk associated with the use of the contraceptive pill for IVF scheduling, especially in women over 35.
Administration of corifollitropin alfa, an FSH with extended release kinetics, seems particularly interesting for a synchronous recruitment of follicles after homogenization of the cohort. In the Pursue study, an equivalent efficacy has been shown with the daily administration of 300 IU FSH and corifollitropin alfa in patients over 35 years .
The objective of this study is to evaluate the impact of the response to ovarian stimulation with corifollitropin alfa of E2 scheduling versus no scheduling for women over 38 years, age at which declining of ovarian reserve usually begins. The management of these patients in terms of organization of the center is also evaluated.
The scheduling of IVF cycles represents a double benefit. On one hand, to enable a "synchronization" of the follicular cohort for a best response and a higher number of mature oocytes. On the other hand, a more efficient organization for both the center (avoiding retrievals on weekends and public holidays, organize and distribute equally the activity, reduce cost operations) and couples (personal and professional organization). This can be done with pills but there are controversial data on its impact on the chances of birth. It has been shown that estrogen scheduling provides opportunities for success equivalent to the absence of scheduling for patients with good prognosis . If this study confirms the initial hypothesis, it will show that a less favorable public can profit from the benefits of scheduling by estrogen on both the organization of the attempt and the chances of pregnancy through better ovarian response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm E2: With estrogens pretreatment | Experimental | Drug: EstrogensThe estrogens pretreatment will began between the day 20 and the day 24 of an ovarian cycle and should be continued until Wednesday beyond the onset of menses |
| Arm S: without estrogens pretreatment | No intervention | –No estrogen pretreatment will be delivered |
Who may qualify
- Ages
- 38 to 47 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient of 38 years or more
- Planned in invitro fertilization or intracytoplasmic sperm injection rank 1 or 2 (rank = retrieval with transfer)
- With regular cycles from 26 to 35 days
- Weight > 50 kg and body mass index< or equal to 32
- Affiliation to the general system of French social security and reimbursement for fertility problems
Key exclusion criteria (6 listed)
- Irregular cycles and/or polycystic ovarian syndrome
- Previous History of ovarian hyperstimulation syndrome
- Rank puncture > 2
- Uterine malformation
- Presence of hydrosalpinges
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EstrogensThe estrogens pretreatment will began between the day 20 and the day 24 of an ovarian cycle and should be continued until Wednesday beyond the onset of menses | Drug | Arm E2: With estrogens pretreatment |
Primary outcome
Number of selected oocytes
Time frame: At time of ovarian puncture
14 secondary outcomes
Number of days of pretreatment
Time frame: From inclusion visit date to the beginning of stimulation, up to 15 days
Cancellation rate
Time frame: From date of inclusion visit until the date of embryo transfer, up to 90 days
Number of days of antagonist
Time frame: From date of stimulation until the date of the trigger, up to 30 days
The day of the trigger
Time frame: At time of the trigger
Estradiol rate
Time frame: 8 days from the beginning of stimulation and the day of the trigger
Luteinizing hormone rate
Time frame: 8 days from the beginning of stimulation and the day of the trigger
Progesterone rate
Time frame: 8 days from the beginning of stimulation and the day of the trigger
Follicles number > 10 mm
Time frame: 8 days from the beginning of stimulation
Follicles number > 14 mm
Time frame: From 1 day before the day of trigger or the day of trigger
Number of oocytes in metaphase 2
Time frame: At time of ovarian puncture
Total number of embryos with good quality
Time frame: At time of fertilization procedure
early pregnancy
Time frame: 14 days after embryo transfer
ongoing pregnancy rate
Time frame: 12 weeks after embryo transfer
miscarriage before 12 weeks of amenorrhea
Time frame: From embryo transfer to 12 weeks after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 22296973Blockeel C, Engels S, De Vos M, Haentjens P, Polyzos NP, Stoop D, Camus M, Devroey P. Oestradiol valerate pretreatment in GnRH-antagonist cycles: a randomized controlled trial. Reprod Biomed Online. 2012 Mar;24(3):272-80. doi: 10.1016/j.rbmo.2011.11.012. Epub 2011 Nov 30.
- Background: PubMed 26003273Boostanfar R, Shapiro B, Levy M, Rosenwaks Z, Witjes H, Stegmann BJ, Elbers J, Gordon K, Mannaerts B; Pursue investigators. Large, comparative, randomized double-blind trial confirming noninferiority of pregnancy rates for corifollitropin alfa compared with recombinant follicle-stimulating hormone in a gonadotropin-releasing hormone antagonist controlled ovarian stimulation protocol in older patients undergoing in vitro fertilization. Fertil Steril. 2015 Jul;104(1):94-103.e1. doi: 10.1016/j.fertnstert.2015.04.018. Epub 2015 May 21.
- Background: PubMed 16936304Cedrin-Durnerin I, Bstandig B, Parneix I, Bied-Damon V, Avril C, Decanter C, Hugues JN. Effects of oral contraceptive, synthetic progestogen or natural estrogen pre-treatments on the hormonal profile and the antral follicle cohort before GnRH antagonist protocol. Hum Reprod. 2007 Jan;22(1):109-16. doi: 10.1093/humrep/del340. Epub 2006 Aug 26.
- Background: PubMed 22464760Cedrin-Durnerin I, Guivarc'h-Leveque A, Hugues JN; Groupe d'Etude en Medecine et Endocrinologie de la Reproduction. Pretreatment with estrogen does not affect IVF-ICSI cycle outcome compared with no pretreatment in GnRH antagonist protocol: a prospective randomized trial. Fertil Steril. 2012 Jun;97(6):1359-64.e1. doi: 10.1016/j.fertnstert.2012.02.028. Epub 2012 Mar 28.
- Background: PubMed 23194136Chang X, Wu J. Effects of luteal estradiol pre-treatment on the outcome of IVF in poor ovarian responders. Gynecol Endocrinol. 2013 Mar;29(3):196-200. doi: 10.3109/09513590.2012.736558. Epub 2012 Nov 30.
- Background: PubMed 25955224Escriva AM, Diaz-Garcia C, Monterde M, Rubio JM, Pellicer A. Antral Follicle Priming Before Intracytoplasmic Sperm Injection in Previously Diagnosed Low Responders: A Randomized Controlled Trial (FOLLPRIM). J Clin Endocrinol Metab. 2015 Jul;100(7):2597-605. doi: 10.1210/jc.2015-1194. Epub 2015 May 8.
- Background: PubMed 14645194Fanchin R, Salomon L, Castelo-Branco A, Olivennes F, Frydman N, Frydman R. Luteal estradiol pre-treatment coordinates follicular growth during controlled ovarian hyperstimulation with GnRH antagonists. Hum Reprod. 2003 Dec;18(12):2698-703. doi: 10.1093/humrep/deg516.
- Background: PubMed 21868004Guivarc'h-Leveque A, Homer L, Arvis P, Broux PL, Moy L, Priou G, Vialard J, Colleu D, Dewailly D. Programming in vitro fertilization retrievals during working days after a gonadotropin-releasing hormone antagonist protocol with estrogen pretreatment: does the length of exposure to estradiol impact on controlled ovarian hyperstimulation outcomes? Fertil Steril. 2011 Oct;96(4):872-6. doi: 10.1016/j.fertnstert.2011.07.1138. Epub 2011 Aug 24.
- Background: PubMed 24074027Hauzman EE, Zapata A, Bermejo A, Iglesias C, Pellicer A, Garcia-Velasco JA. Cycle scheduling for in vitro fertilization with oral contraceptive pills versus oral estradiol valerate: a randomized, controlled trial. Reprod Biol Endocrinol. 2013 Sep 28;11:96. doi: 10.1186/1477-7827-11-96.
- Background: PubMed 26891977Nielsen AP, Korsholm AS, Lemmen JG, Sylvest R, Sopa N, Nyboe Andersen A. Selective use of corifollitropin for controlled ovarian stimulation for IVF in patients with low anti-Mullerian hormone. Gynecol Endocrinol. 2016 Aug;32(8):625-628. doi: 10.3109/09513590.2016.1147548. Epub 2016 Feb 18.
- Background: PubMed 23442756Polyzos NP, De Vos M, Corona R, Vloeberghs V, Ortega-Hrepich C, Stoop D, Tournaye H. Addition of highly purified HMG after corifollitropin alfa in antagonist-treated poor ovarian responders: a pilot study. Hum Reprod. 2013 May;28(5):1254-60. doi: 10.1093/humrep/det045. Epub 2013 Feb 26.
- Background: PubMed 23887073Reynolds KA, Omurtag KR, Jimenez PT, Rhee JS, Tuuli MG, Jungheim ES. Cycle cancellation and pregnancy after luteal estradiol priming in women defined as poor responders: a systematic review and meta-analysis. Hum Reprod. 2013 Nov;28(11):2981-9. doi: 10.1093/humrep/det306. Epub 2013 Jul 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne GUIVARC'H - LEVEQUE, MD principal investigator
Clinique de la Sagesse
Isabelle CEDRIN - DURNERIN, MD principal investigator
CHU Jean Verdier - APHP
Nathalie MASSIN, MD principal investigator
CHI Créteil
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Estrogens in people with Infertility, run by Centre Hospitalier Intercommunal Creteil at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of selected oocytes (time frame: At time of ovarian puncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02884245, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.