Polycystic Ovary SyndromeNCT04325295
LOD vs Gn in Anovulatory PCOs Resistant to First Line Agents
A study testing Laparoscopic ovarian drilling and Recombinant FSH (rFSH) in people with Polycystic Ovary Syndrome and Anovulation, run by Assiut University.
Trial summary
PCOS is a complex disease that is diagnosed by the presence of two of the following three: oligo/anovulation, clinical and/or biochemical hyperandrogenism, or polycystic ovaries by ultrasound . PCOS affects 4% to 21% of females in reproductive age . Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Anovulation
- What is being tested?
- Laparoscopic ovarian drilling and Recombinant FSH (rFSH)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Aug 2022
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- anovulatory polycystic ovary syndrome resistant to first line ovulation induction.
- Polycystic ovary Syndrome defined by Rotterdam's criteria 2003
- Clomiphene resistance defined as failure to ovulate with a dose of 150mg per day for 5 days for 3 cycles
- Letrozole resistance defined as failure to ovulate with a dose of 7.5 mg per day for 5 days for 3 cycles
Who cannot join
- women's age < 18 years or ≥ 40 years.
- BMI > 40 kg/m2
- Patient with hyperprolactinaemia (serum prolactin above normal limits)
- Patients with hypogonadotropic hypogonadism (low serum FSH and LH)
- Patients with anovulation due to ovarian failure (serum FSH higher than normal limits)
- Male infertility
Show all 10Show fewer
- Tubal abnormality, Known endometriosis, adenomyosis, uterine myomas or any other detected cause of female infertility
- History of ovarian surgery as laparoscopic ovarian drilling, ovarian cystectomy or oophorectomy
- History of pelvic radiation
- Patient recently treated with any type of induction of ovulation in the last three months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Laparoscopic Ovarian Drilling Versus Gonadotrophins for Anovulatory Polycystic Ovary Syndrome Resistant to First Line Ovulation Induction: a Randomized Controlled Trial.
PCOS is a complex disease that is diagnosed by the presence of two of the following three: oligo/anovulation, clinical and/or biochemical hyperandrogenism, or polycystic ovaries by ultrasound . PCOS affects 4% to 21% of females in reproductive age . Although subfertility is abundant in women with PCOS, a majority of these women will achieve pregnancy naturally or by treatment.
Different treatment modalities are present for ovulation induction. Life style modifications including weight loss are encouraged for those who are overweight or obese. Pharmacological induction of ovulation represent the first line therapy for induction of ovulation. Options include aromatase inhibitors (Letrozole), Clomiphene Citrate (CC) or Metformin, alone or in combinations.
Read more
For second line treatment either Gonadotropins (Gn) or laparoscopic ovarian surgery (LOS) are the recommended options .
the objective of the trial is to study the effectiveness and safetey of surgical induction of ovulation strategy and compare it to medical induction strategy with Gonadotropins
Read the detailed description
PCOS is a complex disease that is diagnosed by the presence of two of the following three: oligo/anovulation, clinical and/or biochemical hyperandrogenism, or polycystic ovaries by ultrasound . PCOS affects 4% to 21% of females in reproductive age . Although subfertility is abundant in women with PCOS, a majority of these women will achieve pregnancy naturally or by treatment.
Different treatment modalities are present for ovulation induction. Life style modifications including weight loss are encouraged for those who are overweight or obese. Pharmacological induction of ovulation represent the first line therapy for induction of ovulation. Options include aromatase inhibitors (Letrozole), Clomiphene Citrate (CC) or Metformin, alone or in combinations.
For second line treatment either Gonadotropins (Gn) or laparoscopic ovarian surgery (LOS) are the recommended options .
Systematic reviews done comparing LOD to Gn found no differences in live birth, clinical pregnancy or miscarriage rates. However, there was significant decrease in OHSS and multiple pregnancies with LOD . Giving these advantages together with being cheap, the surgical strategy may be a more favorable choice as second line treatment of anovulation . Also several randomised controlled trial (RCTs) reported normalization of ovarian reserve parameters after LOD, making it a long-lasting option compared to the one-cycle effect of medical treatment the objective of the trial is to study the effectiveness and safetey of surgical induction of ovulation strategy and compare it to medical induction strategy with Gonadotropins
- Conditions
- Polycystic Ovary Syndrome, Anovulation
- Being tested
- Laparoscopic ovarian drilling, Recombinant FSH (rFSH)
- Keywords
- Laparoscopic ovarian drilling, Gonadotrophins, Polycystic ovary syndrome, Anovulation, PCOs, Clomiphene resistant, Letrozole resistant
- Medical subject headings
- Polycystic Ovary Syndrome, Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ovarian drillingProcedure or surgery
LOD will be done in the follicular phase.Follow up will be done on the next cycle by performing a TVUS examination at CD 13 and measuring the dominant follicles. Ovulation is considered if a follicle reached > 17 mm and is confirmed by measuring serum progesterone at CD 21.If ovulation is not achieved in the cycle following LOD, women will be prescribed Letrozole by the dose of 2.5 mg daily for 5 days starting from CD 3, and ovulation monitoring will be done similarly. If ovulation is not achieved, the dose is increased by 2.5 mg daily in the subsequent cycle until reaching the maximum dose of 7.5 mg daily for a total of 3 cycles.With persistent resistance to Letrozole in inducing ovulation, Gn will be prescribed for 3 cycles as in Gonadotrophin strategy
Recombinant FSH (rFSH)Drug
A low-dose step-up protocol will be implemented. This starts on CD 3,The rFSH will be given through (IM) or(SC) injections with 75 IU and will be given once daily.Monitoring of the treatment will be done on CD 7 by TVUS and serum E2. Monitoring is individualized according to the response. Depending on the response and follicular growth, the dose may be adjusted by increasing 37.5 IU. If follicular growth failed, the dose is furtherly increased by the same amount until at least one follicle reaches 10 mm. The dose is maintained until at least one follicle reaches a diameter of 18 mm and no more than 2 follicles are bigger than 15 mm. Once reaching the desired diameter, the rFSH will be stopped and a trigger of ovulation by an IM injection of 5000 IU of hCG and sexual intercourse is encouraged on the day of trigger and the next day. Then serum P will be done 7 days after hCG injection to detect the occurrence of ovulation.
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment strategy: | Active comparator | Not described Receives: Procedure: Laparoscopic ovarian drilling |
| Gonadotrophins treatment strategy | Active comparator | Not described Receives: Drug: Recombinant FSH (rFSH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth
defined as the number of births resulted in live babies after the age of viability (24th week of pregnancy)
Measured: within 12 months after of end treatment strategy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study startDec 2020 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Mustafa Attyia, Assiut University
- Investigators
- Sayed A Abdallah, Study director, Professor of obstetric and Gynecology,Faculty of Medicine,Assuit University OEssam R Othman, Study director, Assistant Professor of Obstetrics and Gynecology,Faculty of Medicine, Assuit UniversityMustafa B Mohammed, Study director, Assistant professor of Obstetrics and Gynecology, Faculty of Medicine,Assuit UniversityAhmed M Alaa Eldin, Study director, Lecturer of Obstetrics and Gynecology,Faculty of Medicine,Assuit UniversityKarim S Abdallah, Study director, Assistant lecturer of Obstetrics and Gynecology,Faculty of Medicine,Assuit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325295
- Sponsor's protocol ID
- induction resistant PCOs
- Status last verified
- Oct 2020
- First submitted
- 26 Mar 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Farquhar CM, Bhattacharya S, Repping S, Mastenbroek S, Kamath MS, Marjoribanks J, Boivin J. Female subfertility. Nat Rev Dis Primers. 2019 Jan 24;5(1):7. doi: 10.1038/s41572-018-0058-8.
PubMed 30679436Weiss NS, Kostova E, Nahuis M, Mol BWJ, van der Veen F, van Wely M. Gonadotrophins for ovulation induction in women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2019 Jan 16;1(1):CD010290. doi: 10.1002/14651858.CD010290.pub3.
PubMed 30648738Lizneva D, Suturina L, Walker W, Brakta S, Gavrilova-Jordan L, Azziz R. Criteria, prevalence, and phenotypes of polycystic ovary syndrome. Fertil Steril. 2016 Jul;106(1):6-15. doi: 10.1016/j.fertnstert.2016.05.003. Epub 2016 May 24.
PubMed 27233760van Wely M, Bayram N, Bossuyt PM, van der Veen F. Laparoscopic electrocautery of the ovaries versus recombinant FSH in clomiphene citrate-resistant polycystic ovary syndrome. Impact on women's health-related quality of life. Hum Reprod. 2004 Oct;19(10):2244-50. doi: 10.1093/humrep/deh406. Epub 2004 Jul 8.
PubMed 15242999Api M. Is ovarian reserve diminished after laparoscopic ovarian drilling? Gynecol Endocrinol. 2009 Mar;25(3):159-65. doi: 10.1080/09513590802585605.
PubMed 19347705Debras E, Fernandez H, Neveu ME, Deffieux X, Capmas P. Ovarian drilling in polycystic ovary syndrome: Long term pregnancy rate. Eur J Obstet Gynecol Reprod Biol X. 2019 Aug 13;4:100093. doi: 10.1016/j.eurox.2019.100093. eCollection 2019 Oct.
PubMed 31497757Amer SA, Banu Z, Li TC, Cooke ID. Long-term follow-up of patients with polycystic ovary syndrome after laparoscopic ovarian drilling: endocrine and ultrasonographic outcomes. Hum Reprod. 2002 Nov;17(11):2851-7. doi: 10.1093/humrep/17.11.2851.
PubMed 12407038Farquhar C, Brown J, Marjoribanks J. Laparoscopic drilling by diathermy or laser for ovulation induction in anovulatory polycystic ovary syndrome. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD001122. doi: 10.1002/14651858.CD001122.pub4.
PubMed 22696324Nahuis MJ, Oude Lohuis E, Kose N, Bayram N, Hompes P, Oosterhuis GJ, Kaaijk EM, Cohlen BJ, Bossuyt PP, van der Veen F, Mol BW, van Wely M. Long-term follow-up of laparoscopic electrocautery of the ovaries versus ovulation induction with recombinant FSH in clomiphene citrate-resistant women with polycystic ovary syndrome: an economic evaluation. Hum Reprod. 2012 Dec;27(12):3577-82. doi: 10.1093/humrep/des336. Epub 2012 Sep 20.
PubMed 23001778
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Ovarian Drilling Versus Gonadotrophins for Anovulatory Polycystic Ovary Syndrome Resistant to First Line Ovulation Induction: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04325295
- Acronym / sponsor ID
- induction resistant PCOs
- Conditions
- Polycystic Ovary Syndrome, Anovulation
- Keywords
- Laparoscopic ovarian drilling, Gonadotrophins, Polycystic ovary syndrome, Anovulation, PCOs, Clomiphene resistant, Letrozole resistant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 27 Mar 2020 (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.
PCOS is a complex disease that is diagnosed by the presence of two of the following three: oligo/anovulation, clinical and/or biochemical hyperandrogenism, or polycystic ovaries by ultrasound . PCOS affects 4% to 21% of females in reproductive age . Although subfertility is abundant in women with PCOS, a majority of these women will achieve pregnancy naturally or by treatment.
Different treatment modalities are present for ovulation induction. Life style modifications including weight loss are encouraged for those who are overweight or obese. Pharmacological induction of ovulation represent the first line therapy for induction of ovulation. Options include aromatase inhibitors (Letrozole), Clomiphene Citrate (CC) or Metformin, alone or in combinations.
For second line treatment either Gonadotropins (Gn) or laparoscopic ovarian surgery (LOS) are the recommended options .
the objective of the trial is to study the effectiveness and safetey of surgical induction of ovulation strategy and compare it to medical induction strategy with Gonadotropins
Detailed description
PCOS is a complex disease that is diagnosed by the presence of two of the following three: oligo/anovulation, clinical and/or biochemical hyperandrogenism, or polycystic ovaries by ultrasound . PCOS affects 4% to 21% of females in reproductive age . Although subfertility is abundant in women with PCOS, a majority of these women will achieve pregnancy naturally or by treatment.
Different treatment modalities are present for ovulation induction. Life style modifications including weight loss are encouraged for those who are overweight or obese. Pharmacological induction of ovulation represent the first line therapy for induction of ovulation. Options include aromatase inhibitors (Letrozole), Clomiphene Citrate (CC) or Metformin, alone or in combinations.
For second line treatment either Gonadotropins (Gn) or laparoscopic ovarian surgery (LOS) are the recommended options .
Systematic reviews done comparing LOD to Gn found no differences in live birth, clinical pregnancy or miscarriage rates. However, there was significant decrease in OHSS and multiple pregnancies with LOD . Giving these advantages together with being cheap, the surgical strategy may be a more favorable choice as second line treatment of anovulation . Also several randomised controlled trial (RCTs) reported normalization of ovarian reserve parameters after LOD, making it a long-lasting option compared to the one-cycle effect of medical treatment the objective of the trial is to study the effectiveness and safetey of surgical induction of ovulation strategy and compare it to medical induction strategy with Gonadotropins
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment strategy: | Active comparator | Procedure: Laparoscopic ovarian drilling |
| Gonadotrophins treatment strategy | Active comparator | Drug: Recombinant FSH (rFSH) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- anovulatory polycystic ovary syndrome resistant to first line ovulation induction.
- Polycystic ovary Syndrome defined by Rotterdam's criteria 2003
- Clomiphene resistance defined as failure to ovulate with a dose of 150mg per day for 5 days for 3 cycles
- Letrozole resistance defined as failure to ovulate with a dose of 7.5 mg per day for 5 days for 3 cycles
Key exclusion criteria (10 listed)
- women's age < 18 years or ≥ 40 years.
- BMI > 40 kg/m2
- Patient with hyperprolactinaemia (serum prolactin above normal limits)
- Patients with hypogonadotropic hypogonadism (low serum FSH and LH)
- Patients with anovulation due to ovarian failure (serum FSH higher than normal limits)
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 |
|---|---|---|
| Laparoscopic ovarian drillingLOD will be done in the follicular phase.Follow up will be done on the next cycle by performing a TVUS examination at CD 13 and measuring the dominant follicles. Ovulation is considered if a follicle reached > 17 mm and is confirmed by measuring serum progesterone at CD 21.If ovulation is not achieved in the cycle following LOD, women will be prescribed Letrozole by the dose of 2.5 mg daily for 5 days starting from CD 3, and ovulation monitoring will be done similarly. If ovulation is not achieved, the dose is increased by 2.5 mg daily in the subsequent cycle until reaching the maximum dose of 7.5 mg daily for a total of 3 cycles.With persistent resistance to Letrozole in inducing ovulation, Gn will be prescribed for 3 cycles as in Gonadotrophin strategy | Procedure or surgery | Surgical treatment strategy: |
| Recombinant FSH (rFSH)A low-dose step-up protocol will be implemented. This starts on CD 3,The rFSH will be given through (IM) or(SC) injections with 75 IU and will be given once daily.Monitoring of the treatment will be done on CD 7 by TVUS and serum E2. Monitoring is individualized according to the response. Depending on the response and follicular growth, the dose may be adjusted by increasing 37.5 IU. If follicular growth failed, the dose is furtherly increased by the same amount until at least one follicle reaches 10 mm. The dose is maintained until at least one follicle reaches a diameter of 18 mm and no more than 2 follicles are bigger than 15 mm. Once reaching the desired diameter, the rFSH will be stopped and a trigger of ovulation by an IM injection of 5000 IU of hCG and sexual intercourse is encouraged on the day of trigger and the next day. Then serum P will be done 7 days after hCG injection to detect the occurrence of ovulation. | Drug | Gonadotrophins treatment strategy |
Primary outcome
Live Birth
Time frame: within 12 months after of end treatment strategy
defined as the number of births resulted in live babies after the age of viability (24th week of pregnancy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 30679436Farquhar CM, Bhattacharya S, Repping S, Mastenbroek S, Kamath MS, Marjoribanks J, Boivin J. Female subfertility. Nat Rev Dis Primers. 2019 Jan 24;5(1):7. doi: 10.1038/s41572-018-0058-8.
- Background: PubMed 30648738Weiss NS, Kostova E, Nahuis M, Mol BWJ, van der Veen F, van Wely M. Gonadotrophins for ovulation induction in women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2019 Jan 16;1(1):CD010290. doi: 10.1002/14651858.CD010290.pub3.
- Background: PubMed 27233760Lizneva D, Suturina L, Walker W, Brakta S, Gavrilova-Jordan L, Azziz R. Criteria, prevalence, and phenotypes of polycystic ovary syndrome. Fertil Steril. 2016 Jul;106(1):6-15. doi: 10.1016/j.fertnstert.2016.05.003. Epub 2016 May 24.
- Background: PubMed 15242999van Wely M, Bayram N, Bossuyt PM, van der Veen F. Laparoscopic electrocautery of the ovaries versus recombinant FSH in clomiphene citrate-resistant polycystic ovary syndrome. Impact on women's health-related quality of life. Hum Reprod. 2004 Oct;19(10):2244-50. doi: 10.1093/humrep/deh406. Epub 2004 Jul 8.
- Background: PubMed 19347705Api M. Is ovarian reserve diminished after laparoscopic ovarian drilling? Gynecol Endocrinol. 2009 Mar;25(3):159-65. doi: 10.1080/09513590802585605.
- Background: PubMed 31497757Debras E, Fernandez H, Neveu ME, Deffieux X, Capmas P. Ovarian drilling in polycystic ovary syndrome: Long term pregnancy rate. Eur J Obstet Gynecol Reprod Biol X. 2019 Aug 13;4:100093. doi: 10.1016/j.eurox.2019.100093. eCollection 2019 Oct.
- Background: PubMed 12407038Amer SA, Banu Z, Li TC, Cooke ID. Long-term follow-up of patients with polycystic ovary syndrome after laparoscopic ovarian drilling: endocrine and ultrasonographic outcomes. Hum Reprod. 2002 Nov;17(11):2851-7. doi: 10.1093/humrep/17.11.2851.
- Background: PubMed 22696324Farquhar C, Brown J, Marjoribanks J. Laparoscopic drilling by diathermy or laser for ovulation induction in anovulatory polycystic ovary syndrome. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD001122. doi: 10.1002/14651858.CD001122.pub4.
- Background: PubMed 23001778Nahuis MJ, Oude Lohuis E, Kose N, Bayram N, Hompes P, Oosterhuis GJ, Kaaijk EM, Cohlen BJ, Bossuyt PP, van der Veen F, Mol BW, van Wely M. Long-term follow-up of laparoscopic electrocautery of the ovaries versus ovulation induction with recombinant FSH in clomiphene citrate-resistant women with polycystic ovary syndrome: an economic evaluation. Hum Reprod. 2012 Dec;27(12):3577-82. doi: 10.1093/humrep/des336. Epub 2012 Sep 20.
Related trials for Polycystic Ovary Syndrome
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
Sayed A Abdallah study director
Professor of obstetric and Gynecology,Faculty of Medicine,Assuit University O
Essam R Othman study director
Assistant Professor of Obstetrics and Gynecology,Faculty of Medicine, Assuit University
Mustafa B Mohammed study director
Assistant professor of Obstetrics and Gynecology, Faculty of Medicine,Assuit University
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic ovarian drilling and Recombinant FSH (rFSH) in people with Polycystic Ovary Syndrome and Anovulation, run by Assiut University.
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 4 inclusion and 10 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Khaled M Attyia (+201005503250, khaled.hussien@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth (time frame: within 12 months after of end treatment strategy). 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 NCT04325295, which also lists 9 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 14 Oct 2020.