Fertility IssuesNCT05536999
Follicular FSH Serum Level as a Predictor of an Oocyte Yield and Quality in Fertility Preservation Cycles for Women With a Compromised Ovarian Reserve
An observational study of Fertility Issues, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The incorporation of ovarian reserve tests in IVF management started after initial publications indicating a potential role for basal FSH in predicting pregnancy outcome after IVF and in counseling patients (1,2). Read more about this study
- Who is it for?
- Ages 18 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Issues
- What is being tested?
- Blood sample taking , like to measure hormonal level like LH, FSH, Perlakan ,in a follicular fluid after the oocyte retrival
- How many people
- 64 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2022to 1 Aug 2024
- Phase
- Observational
- 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 18 to 41 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women between ages 30 -41, who undergo fertility preservation , were diagnosed as having a low ovarian reservoir and were acknowledge as eligible for oocyte cryopreservation coverage according to the health ministry decision .
Who may be able to join
- Fertility preservation patients
- Age 30-41
- Low ovarian reservoir
Who cannot join
- Women with a single ovary
- Women planned to undergo in vitro fertilization
- Women with cancer diagnosis
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Mount Scoupus
Jerusalem
Ilana Weizel, MD, +972587803318, ilanave@hadassah.org.il
Anat Hershko, MD, +972549170084, anat.hershko@gmail.com
About this study
Official title: Follicular FSH Serum Level as a Predictor of an Oocyte Quality and Yield in Fertility Preservation Cycles for Women With a Compromised Ovarian Reserve.
The incorporation of ovarian reserve tests in IVF management started after initial publications indicating a potential role for basal FSH in predicting pregnancy outcome after IVF and in counseling patients (1,2). Since these first publications, a large body of additional work on basal FSH and several other tests has been published, often with inconsistent findings on the magnitude and direction of the predictive effect. (3). Level of basal FSH at the start of IVF, in patients aged younger than 40 years, was shown to predict an oocyte yield by several authors, but wasn't related to pregnancy or implantation rates. (4).
Social egg freezing refers to the cryopreservation of mature oocytes on an elective basis for the purpose of delayed childbearing. Many women now have a solution to "bridge the gap between reproductive aging and readiness to have children. Assessment of ovarian reserve enables estimation of the remaining egg pool and can be compared with other women her age. Ovarian reserve tests aim at identifying women at risk of hypo or hyper response to ovarian stimulation: it can possibly detect reproductive lifespan and approximate menopausal timing, assist in counseling family planning and to optimize ovarian response whilst minimizing risks (5).
Read more
In Israel, retention of fertility for non-medical reasons is offered for women who have reached the age of 30, but have not yet reached the age of 41. These women may undergo up to 4 retrievals or until 20 eggs are obtained (whichever occurs earlier). The 2022 Health Services, decided to include, for the first-time, to cover cryopreservation for women with a diminished ovarian reserve (6). This unique population is currently addressing our clinic in order to preserve fertility. One of the criteria for coverage entitlement is elevated day 3 FSH level.
The tests used for assessing ovarian reserve include basal day -3 follicle stimulating hormone (FSH, introduced in 1998). Clomiphene citrate challenge test (CCCT, 1989), gonadotropins releasing - hormone agonist stimulation test (GAST, 1989), Inhibin -B (1997), antral follicle count (AFC, 1997) and antimullerian hormone (AMH, 2002.) (7) Measurement of basal FSH is relatively inexpensive, imposes no major burden on the patient, and is widely used in assisted reproductive technology programs.
Follicular fluid provides a very important microenvironment for the development of oocytes. It is reasonable to think that some biochemical characteristics may play a critical role in determining oocyte quality and the subsequent potential to achieve fertilization and embryo development. Components may also provide information on metabolic changes in blood serum, as the circulating biochemical milieu may be reflected in it's composition .
In our current research we wish to assess cycle yield as related to basal FSH level among women diagnosed as having a low ovarian reservoir and were acknowledge as eligible for oocyte cryopreservation coverage. We also would like to measure hormonal level like LH, FSH, Perlakan ,in a follicular fluid after the oocyte retrieval in order to asses the microenvironment .
Read the detailed description
As a routine monitoring, blood sample is drawn in the early follicular phase (day 3 ). FSH will be documented at this point, prior to IVF cycle initiation. Following this point the treatment will follow routine monitoring including Estradiol measurement, progesteroen measurement and an ultrasound.
Follicular fluid collection: After the laboratory licked the eggs follicular fluid will be aspirated and collected.
The database will include in addition : demographic variables (age, BMI, background morbidities , parity , menstrual parameters ) , number of follicles documented by US ,number of oocytes retrieved number of metaphase II oocytes
Inclusion criteria-
- Ages 30 -41
- Patients who undergo fertility preservation
- Patients with a low ovarian reservoir Exclusion criteria-
- Women with a medical indication for preservation
- Women with a single ovary
- Women planned to undergo in vitro fertilization STATISTICAL ANALYSIS - Descriptive statistics will be used to analyze demographic variables. Correlation coefficients will be used to which evaluate basal FSH , oocyte yield and follicular fluid content . All data will be anonymized prior to data extraction and analysis.
BUDJET- All the laboratory data and ultrasound monitoring are fully covered by the Ministry of Health . Data extraction and analysis will be performed by the IVF unit physicians
- Conditions
- Fertility Issues
- Being tested
- Blood sample taking , like to measure hormonal level like LH, FSH, Perlakan ,in a follicular fluid after the oocyte retrival
- Keywords
- FSH, Social egg freezing, oocyte retrival, follicular fluid , basal FSH, low ovarian reserve
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample taking , like to measure hormonal level like LH, FSH, Perlakan ,in a follicular fluid after the oocyte retrivalOther
Blood test measure basal FSH, follicular fluid testing
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 3 elevated FSH level is variable in the same patient and is predictive to lower oocyte yield and quality
Measurement of basal FSH in a blood and testing the follicular fluid after oocyte retrieval
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Aug 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilana Weizel, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536999
- Sponsor's protocol ID
- HMO-0882-22
- Status last verified
- Oct 2022
- First submitted
- 8 Sep 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Every patient receives her own unique number
Publications
Muasher SJ, Oehninger S, Simonetti S, Matta J, Ellis LM, Liu HC, Jones GS, Rosenwaks Z. The value of basal and/or stimulated serum gonadotropin levels in prediction of stimulation response and in vitro fertilization outcome. Fertil Steril. 1988 Aug;50(2):298-307. doi: 10.1016/s0015-0282(16)60077-8.
PubMed 3135206Roberts JE, Spandorfer S, Fasouliotis SJ, Kashyap S, Rosenwaks Z. Taking a basal follicle-stimulating hormone history is essential before initiating in vitro fertilization. Fertil Steril. 2005 Jan;83(1):37-41. doi: 10.1016/j.fertnstert.2004.06.062.
PubMed 15652884Bancsi LF, Broekmans FJ, Mol BW, Habbema JD, te Velde ER. Performance of basal follicle-stimulating hormone in the prediction of poor ovarian response and failure to become pregnant after in vitro fertilization: a meta-analysis. Fertil Steril. 2003 May;79(5):1091-100. doi: 10.1016/s0015-0282(03)00078-5.
PubMed 12738501Al-Azemi M, Killick SR, Duffy S, Pye C, Refaat B, Hill N, Ledger W. Multi-marker assessment of ovarian reserve predicts oocyte yield after ovulation induction. Hum Reprod. 2011 Feb;26(2):414-22. doi: 10.1093/humrep/deq339. Epub 2010 Dec 8.
PubMed 21147822Revelli A, Delle Piane L, Casano S, Molinari E, Massobrio M, Rinaudo P. Follicular fluid content and oocyte quality: from single biochemical markers to metabolomics. Reprod Biol Endocrinol. 2009 May 4;7:40. doi: 10.1186/1477-7827-7-40.
PubMed 19413899Behre HM. Clinical Use of FSH in Male Infertility. Front Endocrinol (Lausanne). 2019 May 24;10:322. doi: 10.3389/fendo.2019.00322. eCollection 2019.
PubMed 31178827Danis RB, Sriprasert I, Ho JR, McGinnis LK, Kumar A, Stanczyk FZ. Association of bioavailable inhibin B and oocyte yield in controlled ovarian stimulation. F S Rep. 2021 Mar 31;2(2):189-194. doi: 10.1016/j.xfre.2021.03.005. eCollection 2021 Jun.
PubMed 34278353Broer SL, van Disseldorp J, Broeze KA, Dolleman M, Opmeer BC, Bossuyt P, Eijkemans MJ, Mol BW, Broekmans FJ; IMPORT study group. Added value of ovarian reserve testing on patient characteristics in the prediction of ovarian response and ongoing pregnancy: an individual patient data approach. Hum Reprod Update. 2013 Jan-Feb;19(1):26-36. doi: 10.1093/humupd/dms041. Epub 2012 Nov 27.
PubMed 23188168Leroy JL, Vanholder T, Delanghe JR, Opsomer G, Van Soom A, Bols PE, Dewulf J, de Kruif A. Metabolic changes in follicular fluid of the dominant follicle in high-yielding dairy cows early post partum. Theriogenology. 2004 Sep 15;62(6):1131-43. doi: 10.1016/j.theriogenology.2003.12.017.
PubMed 15289052Talbot P, Dandekar P. Perivitelline space: does it play a role in blocking polyspermy in mammals? Microsc Res Tech. 2003 Jul 1;61(4):349-57. doi: 10.1002/jemt.10348.
PubMed 12811740
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular FSH Serum Level as a Predictor of an Oocyte Quality and Yield in Fertility Preservation Cycles for Women With a Compromised Ovarian Reserve.
- ClinicalTrials.gov ID
- NCT05536999
- Acronym / sponsor ID
- HMO-0882-22
- Conditions
- Fertility Issues
- Keywords
- FSH, Social egg freezing, oocyte retrival, follicular fluid , basal FSH, low ovarian reserve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 13 Sep 2022 (actual)
- 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.
The incorporation of ovarian reserve tests in IVF management started after initial publications indicating a potential role for basal FSH in predicting pregnancy outcome after IVF and in counseling patients (1,2). Since these first publications, a large body of additional work on basal FSH and several other tests has been published, often with inconsistent findings on the magnitude and direction of the predictive effect. (3). Level of basal FSH at the start of IVF, in patients aged younger than 40 years, was shown to predict an oocyte yield by several authors, but wasn't related to pregnancy or implantation rates. (4).
Social egg freezing refers to the cryopreservation of mature oocytes on an elective basis for the purpose of delayed childbearing. Many women now have a solution to "bridge the gap between reproductive aging and readiness to have children. Assessment of ovarian reserve enables estimation of the remaining egg pool and can be compared with other women her age. Ovarian reserve tests aim at identifying women at risk of hypo or hyper response to ovarian stimulation: it can possibly detect reproductive lifespan and approximate menopausal timing, assist in counseling family planning and to optimize ovarian response whilst minimizing risks (5).
In Israel, retention of fertility for non-medical reasons is offered for women who have reached the age of 30, but have not yet reached the age of 41. These women may undergo up to 4 retrievals or until 20 eggs are obtained (whichever occurs earlier). The 2022 Health Services, decided to include, for the first-time, to cover cryopreservation for women with a diminished ovarian reserve (6). This unique population is currently addressing our clinic in order to preserve fertility. One of the criteria for coverage entitlement is elevated day 3 FSH level.
The tests used for assessing ovarian reserve include basal day -3 follicle stimulating hormone (FSH, introduced in 1998). Clomiphene citrate challenge test (CCCT, 1989), gonadotropins releasing - hormone agonist stimulation test (GAST, 1989), Inhibin -B (1997), antral follicle count (AFC, 1997) and antimullerian hormone (AMH, 2002.) (7) Measurement of basal FSH is relatively inexpensive, imposes no major burden on the patient, and is widely used in assisted reproductive technology programs.
Follicular fluid provides a very important microenvironment for the development of oocytes. It is reasonable to think that some biochemical characteristics may play a critical role in determining oocyte quality and the subsequent potential to achieve fertilization and embryo development. Components may also provide information on metabolic changes in blood serum, as the circulating biochemical milieu may be reflected in it's composition .
In our current research we wish to assess cycle yield as related to basal FSH level among women diagnosed as having a low ovarian reservoir and were acknowledge as eligible for oocyte cryopreservation coverage. We also would like to measure hormonal level like LH, FSH, Perlakan ,in a follicular fluid after the oocyte retrieval in order to asses the microenvironment .
Detailed description
As a routine monitoring, blood sample is drawn in the early follicular phase (day 3 ). FSH will be documented at this point, prior to IVF cycle initiation. Following this point the treatment will follow routine monitoring including Estradiol measurement, progesteroen measurement and an ultrasound.
Follicular fluid collection: After the laboratory licked the eggs follicular fluid will be aspirated and collected.
The database will include in addition : demographic variables (age, BMI, background morbidities , parity , menstrual parameters ) , number of follicles documented by US ,number of oocytes retrieved number of metaphase II oocytes
Inclusion criteria-
- Ages 30 -41
- Patients who undergo fertility preservation
- Patients with a low ovarian reservoir Exclusion criteria-
- Women with a medical indication for preservation
- Women with a single ovary
- Women planned to undergo in vitro fertilization STATISTICAL ANALYSIS - Descriptive statistics will be used to analyze demographic variables. Correlation coefficients will be used to which evaluate basal FSH , oocyte yield and follicular fluid content . All data will be anonymized prior to data extraction and analysis.
BUDJET- All the laboratory data and ultrasound monitoring are fully covered by the Ministry of Health . Data extraction and analysis will be performed by the IVF unit physicians
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women between ages 30 -41, who undergo fertility preservation , were diagnosed as having a low ovarian reservoir and were acknowledge as eligible for oocyte cryopreservation coverage according to the health ministry decision .
Key inclusion criteria (3 listed)
- Fertility preservation patients
- Age 30-41
- Low ovarian reservoir
Key exclusion criteria (3 listed)
- Women with a single ovary
- Women planned to undergo in vitro fertilization
- Women with cancer diagnosis
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 |
|---|---|---|
| Blood sample taking , like to measure hormonal level like LH, FSH, Perlakan ,in a follicular fluid after the oocyte retrivalBlood test measure basal FSH, follicular fluid testing | Other | – |
Primary outcome
Day 3 elevated FSH level is variable in the same patient and is predictive to lower oocyte yield and quality
Time frame: 2 years
Measurement of basal FSH in a blood and testing the follicular fluid after oocyte retrieval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Background: PubMed 3135206Muasher SJ, Oehninger S, Simonetti S, Matta J, Ellis LM, Liu HC, Jones GS, Rosenwaks Z. The value of basal and/or stimulated serum gonadotropin levels in prediction of stimulation response and in vitro fertilization outcome. Fertil Steril. 1988 Aug;50(2):298-307. doi: 10.1016/s0015-0282(16)60077-8.
- Background: PubMed 15652884Roberts JE, Spandorfer S, Fasouliotis SJ, Kashyap S, Rosenwaks Z. Taking a basal follicle-stimulating hormone history is essential before initiating in vitro fertilization. Fertil Steril. 2005 Jan;83(1):37-41. doi: 10.1016/j.fertnstert.2004.06.062.
- Background: PubMed 12738501Bancsi LF, Broekmans FJ, Mol BW, Habbema JD, te Velde ER. Performance of basal follicle-stimulating hormone in the prediction of poor ovarian response and failure to become pregnant after in vitro fertilization: a meta-analysis. Fertil Steril. 2003 May;79(5):1091-100. doi: 10.1016/s0015-0282(03)00078-5.
- Background: PubMed 21147822Al-Azemi M, Killick SR, Duffy S, Pye C, Refaat B, Hill N, Ledger W. Multi-marker assessment of ovarian reserve predicts oocyte yield after ovulation induction. Hum Reprod. 2011 Feb;26(2):414-22. doi: 10.1093/humrep/deq339. Epub 2010 Dec 8.
- Background: PubMed 19413899Revelli A, Delle Piane L, Casano S, Molinari E, Massobrio M, Rinaudo P. Follicular fluid content and oocyte quality: from single biochemical markers to metabolomics. Reprod Biol Endocrinol. 2009 May 4;7:40. doi: 10.1186/1477-7827-7-40.
- Background: PubMed 31178827Behre HM. Clinical Use of FSH in Male Infertility. Front Endocrinol (Lausanne). 2019 May 24;10:322. doi: 10.3389/fendo.2019.00322. eCollection 2019.
- Background: PubMed 34278353Danis RB, Sriprasert I, Ho JR, McGinnis LK, Kumar A, Stanczyk FZ. Association of bioavailable inhibin B and oocyte yield in controlled ovarian stimulation. F S Rep. 2021 Mar 31;2(2):189-194. doi: 10.1016/j.xfre.2021.03.005. eCollection 2021 Jun.
- Background: PubMed 23188168Broer SL, van Disseldorp J, Broeze KA, Dolleman M, Opmeer BC, Bossuyt P, Eijkemans MJ, Mol BW, Broekmans FJ; IMPORT study group. Added value of ovarian reserve testing on patient characteristics in the prediction of ovarian response and ongoing pregnancy: an individual patient data approach. Hum Reprod Update. 2013 Jan-Feb;19(1):26-36. doi: 10.1093/humupd/dms041. Epub 2012 Nov 27.
- Background: PubMed 15289052Leroy JL, Vanholder T, Delanghe JR, Opsomer G, Van Soom A, Bols PE, Dewulf J, de Kruif A. Metabolic changes in follicular fluid of the dominant follicle in high-yielding dairy cows early post partum. Theriogenology. 2004 Sep 15;62(6):1131-43. doi: 10.1016/j.theriogenology.2003.12.017.
- Background: PubMed 12811740Talbot P, Dandekar P. Perivitelline space: does it play a role in blocking polyspermy in mammals? Microsc Res Tech. 2003 Jul 1;61(4):349-57. doi: 10.1002/jemt.10348.
- Individual participant dataSharing planned: Undecided. Every patient receives her own unique number
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Issues, run by Hadassah Medical Organization at 1 site in Israel.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilana Weizel, MD (+972587803318, ilanave@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 3 elevated FSH level is variable in the same patient and is predictive to lower oocyte yield and quality (time frame: 2 years). 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 NCT05536999, which also lists 10 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 17 Oct 2022.