Clinical trial · Observational
Progesterone Primed Ovarian Stimulation Versus GnRH Antagonist Protocols in Women With Polycystic Ovarian Syndrome
Progesterone Primed Ovarian Stimulation Versus Gonadotrophin-Releasing Hormone Antagonist in Women With Polycystic Ovarian Syndrome
NCT06812559CI-TRIAL-00086447completedClinicalTrials.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 purpose of this study is to compare the use of the progesterone-primed ovarian stimulation protocol versus GnRH antagonist protocol in women with polycystic ovarian syndrome (PCOS) regarding the number of oocytes retrieved, percentage of MII oocytes, and the rate of good quality blastocysts available for cryopreservation.
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 |
|---|---|---|---|
| Controlled Ovarian Hyperstimulation | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GnRH antagonist (Cetrorelix) | Drug | — | UNRESOLVED |
| Progesterone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Progesterone-primed ovarian stimulation Group
- description
- • A daily dose of 20 mg dydrogesterone (2 Duphastone 10 mg tablets) will be added from day 1 or 2 of the menstrual cycle and will be continued till the day of the GnRH agonist trigger.
- interventionNames
- Drug: Progesterone
- label
- Antagonist protocol
- description
- • GnRH antagonist (Cetrotide 0.25 mg) subcutaneous injection will be added daily from the 6th day of ovarian stimulation and will be continued till the day of the GnRH agonist trigger.
- interventionNames
- Drug: GnRH antagonist (Cetrorelix)
Primary outcomes (3)
- measure
- Number of oocytes retrieved (ovarian response).
- timeFrame
- Baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 37 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female age \<37 years. 2. Body mass index (BMI) between (≥18 kg/m2 and ≤35 kg/m2). 3. Polycystic ovarian syndrome patients (according to Rotterdam criteria). 4. Patients suffering from primary or secondary infertility who are candidates for ICSI. Exclusion Criteria: 1. Uncorrected Uterine factor of infertility: intrauterine adhesions, submucosal fibroids, and septate uterus. 2. Severe male factor infertility
References
Publications (14)
- BACKGROUNDLainas TG, Sfontouris IA, Zorzovilis IZ, Petsas GK, Lainas GT, Alexopoulou E, Kolibianakis EM. Flexible GnRH antagonist protocol versus GnRH agonist long protocol in patients with polycystic ovary syndrome treated for IVF: a prospective randomised controlled trial (RCT). Hum Reprod. 2010 Mar;25(3):683-9. doi: 10.1093/humrep/dep436. Epub 2009 Dec 15. PMID 20008886
- BACKGROUNDGriesinger G, Diedrich K, Tarlatzis BC, Kolibianakis EM. GnRH-antagonists in ovarian stimulation for IVF in patients with poor response to gonadotrophins, polycystic ovary syndrome, and risk of ovarian hyperstimulation: a meta-analysis. Reprod Biomed Online. 2006 Nov;13(5):628-38. doi: 10.1016/s1472-6483(10)60652-9. PMID 17169171
- BACKGROUNDAl-Inany HG, Youssef MA, Ayeleke RO, Brown J, Lam WS, Broekmans FJ. Gonadotrophin-releasing hormone antagonists for assisted reproductive technology. Cochrane Database Syst Rev. 2016 Apr 29;4(4):CD001750. doi: 10.1002/14651858.CD001750.pub4. PMID 27126581
- BACKGROUNDToftager M, Bogstad J, Lossl K, Praetorius L, Zedeler A, Bryndorf T, Nilas L, Pinborg A. Cumulative live birth rates after one ART cycle including all subsequent frozen-thaw cycles in 1050 women: secondary outcome of an RCT comparing GnRH-antagonist and GnRH-agonist protocols. Hum Reprod. 2017 Mar 1;32(3):556-567. doi: 10.1093/humrep/dew358. PMID 28130435
- BACKGROUNDDepalo R, Jayakrishan K, Garruti G, Totaro I, Panzarino M, Giorgino F, Selvaggi LE. GnRH agonist versus GnRH antagonist in in vitro fertilization and embryo transfer (IVF/ET). Reprod Biol Endocrinol. 2012 Apr 13;10:26. doi: 10.1186/1477-7827-10-26. PMID 22500852
- BACKGROUNDMessinis IE. Ovarian feedback, mechanism of action and possible clinical implications. Hum Reprod Update. 2006 Sep-Oct;12(5):557-71. doi: 10.1093/humupd/dml020. Epub 2006 May 3. PMID 16672246
- Zhou R, Dong M, Huang L, Wang S, Fan L, Liang X, Zhang X, Liu F. Comparison of cumulative live birth rates between progestin-primed ovarian stimulation protocol and gonadotropin-releasing hormone antagonist protocol in different populations. Front Endocrinol (Lausanne). 2023 Apr 18;14:1117513. doi: 10.3389/fendo.2023.1117513. eCollection 2023.