Clinical trial · Interventional
Polycystic Ovary Syndrome (PCOS) and In Vitro Fertilization (IVF): A Comparison Between Standard Long Protocol Versus an Antagonist Protocol Starting on Day 1
PCOS and IVF: A Comparison Between Standard Long Protocol Versus an Antagonist Protocol Starting on Day 1
NCT00883766CI-TRIAL-00007518terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this study is to compare two different IVF-stimulation protocols in patients affected by PCOS: the use of a Gonadotropin-releasing hormone (GnRH) - antagonist starting on day 1 of controlled ovarian hyperstimulation (COH) versus a standard long agonist protocol; in order to assess whether it affects the number and quality of Metaphase II (MII) oocytes while reducing the risk of hyperstimulation. Since PCOS patients are also likely to be insulin resistant we also aim to evaluate how metformin affects tha IVF stimulation outcome.
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 |
|---|---|---|---|
| In Vitro Fertilization | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Controlled ovarian hyperstimulation for IVF with a long agonist protocol | Other | — | UNRESOLVED |
| Controlled ovarian hyperstimulation for IVF with an antagonist protocol | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Long agonist protocol
- interventionNames
- Other: Controlled ovarian hyperstimulation for IVF with a long agonist protocol
- type
- EXPERIMENTAL
- label
- Antagonist protocol
- interventionNames
- Other: Controlled ovarian hyperstimulation for IVF with an antagonist protocol
Primary outcomes (1)
- measure
- Number of Oocytes MII retrieved per patient
- timeFrame
- 1 Day
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 37 Years
Show eligibility criteria text
Inclusion Criteria: * PCOS patients according to the Rotterdam consensus criteria * Presence of both ovaries * Absence of endometriomas detected at ultrasound * FSH \< 10 IU/L on day 3 of the cycle * E2 \< 80 pg/mL, and Pg \< 1.6 ng/mL at initiation of stimulation Exclusion Criteria: * Congenital adrenal hyperplasia * Cushing's syndrome * Androgen-producing tumours * Hyperprolactinaemia and thyroid dysfunction * Age \> 38 years * Serum FSH levels \> 10 mIU/ml
References
Publications (7)
- BACKGROUNDHeijnen EM, Eijkemans MJ, Hughes EG, Laven JS, Macklon NS, Fauser BC. A meta-analysis of outcomes of conventional IVF in women with polycystic ovary syndrome. Hum Reprod Update. 2006 Jan-Feb;12(1):13-21. doi: 10.1093/humupd/dmi036. Epub 2005 Aug 25. PMID 16123051
- BACKGROUNDAl-Inany H, Aboulghar M. GnRH antagonist in assisted reproduction: a Cochrane review. Hum Reprod. 2002 Apr;17(4):874-85. doi: 10.1093/humrep/17.4.874. PMID 11925376
- BACKGROUNDLainas TG, Petsas GK, Zorzovilis IZ, Iliadis GS, Lainas GT, Cazlaris HE, Kolibianakis EM. Initiation of GnRH antagonist on Day 1 of stimulation as compared to the long agonist protocol in PCOS patients. A randomized controlled trial: effect on hormonal levels and follicular development. Hum Reprod. 2007 Jun;22(6):1540-6. doi: 10.1093/humrep/dem033. Epub 2007 Mar 8. PMID 17347165
- BACKGROUNDTsilchorozidou T, Overton C, Conway GS. The pathophysiology of polycystic ovary syndrome. Clin Endocrinol (Oxf). 2004 Jan;60(1):1-17. doi: 10.1046/j.1365-2265.2003.01842.x. No abstract available. PMID 14678281
- BACKGROUNDCostello MF, Eden JA. A systematic review of the reproductive system effects of metformin in patients with polycystic ovary syndrome. Fertil Steril. 2003 Jan;79(1):1-13. doi: 10.1016/s0015-0282(02)04554-5. PMID 12524053
- BACKGROUNDMoll E, van der Veen F, van Wely M. The role of metformin in polycystic ovary syndrome: a systematic review. Hum Reprod Update. 2007 Nov-Dec;13(6):527-37. doi: 10.1093/humupd/dmm026. Epub 2007 Sep 1. PMID 17767003
- BACKGROUNDTang T, Glanville J, Orsi N, Barth JH, Balen AH. The use of metformin for women with PCOS undergoing IVF treatment. Hum Reprod. 2006 Jun;21(6):1416-25. doi: 10.1093/humrep/del025. Epub 2006 Feb 24. PMID 16501038