Clinical trial · Interventional
LOD vs Gn in Anovulatory PCOs Resistant to First Line Agents
Laparoscopic Ovarian Drilling Versus Gonadotrophins for Anovulatory Polycystic Ovary Syndrome Resistant to First Line Ovulation Induction: a Randomized Controlled Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anovulation | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic ovarian drilling | Procedure | — | UNRESOLVED |
| Recombinant FSH (rFSH) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgical treatment strategy:
- interventionNames
- Procedure: Laparoscopic ovarian drilling
- type
- ACTIVE_COMPARATOR
- label
- Gonadotrophins treatment strategy
- interventionNames
- Drug: Recombinant FSH (rFSH)
Primary outcomes (1)
- measure
- Live Birth
- timeFrame
- within 12 months after of end treatment strategy
- description
- defined as the number of births resulted in live babies after the age of viability (24th week of pregnancy)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 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 Exclusion Criteria: * 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 * 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.
References
Publications (9)
- BACKGROUNDFarquhar 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. PMID 30679436
- BACKGROUNDWeiss 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. PMID 30648738
- BACKGROUNDLizneva 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. PMID 27233760
- BACKGROUNDvan 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. PMID 15242999
- BACKGROUNDApi M. Is ovarian reserve diminished after laparoscopic ovarian drilling? Gynecol Endocrinol. 2009 Mar;25(3):159-65. doi: 10.1080/09513590802585605. PMID 19347705
- BACKGROUNDDebras 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. PMID 31497757
- BACKGROUNDAmer 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.