Progesterone Primed Ovarian Stimulation Versus GnRH Antagonist Protocols in Women With Polycystic Ovarian Syndrome

NCT06812559 | Completed DMC

• 1 other identifier: PPOS vs Antagonist Protocols
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Controlled Ovarian Hyperstimulation; Polycystic Ovarian Syndrome

Keywords

PPOS versus antagonist protocol in PCOS

Outcome Measures

Primary Outcomes (3)

• Number of oocytes retrieved (ovarian response).

  Total number of oocytes retrieved (in both groups)

  Baseline

• Percentage of MII oocytes.

  Number of MII oocytes to the total number of oocytes retrieved (in both groups)

  Baseline

• Rate of good-quality blastocysts available for cryopreservation

  percentage of the number of good-quality blastocysts to the number of 2PN fertilized oocytes cultured

  Baseline

Secondary Outcomes (3)

• Fertilization rate

  Baseline

• Rate of blastocyst formation

  Baseline

• Clinical pregnancy rate after 1st FET

  Baseline

Study Arms (2)

Progesterone-primed ovarian stimulation Group

• 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.

Drug: Progesterone

Antagonist protocol

• 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.

Drug: GnRH antagonist (Cetrorelix)

Interventions

Progesterone DRUG

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.

Also known as: Duphaston 10mg Tablets

Progesterone-primed ovarian stimulation Group

GnRH antagonist (Cetrorelix) DRUG

Subcutaneous injection

Also known as: Cetrotide 0.25mg

Antagonist protocol

Eligibility Criteria

• Age: Up to 37 Years
• Gender Eligibility Details: Female aged less than 37 years old, with PCOS and infertility
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

History taking and examination: * Basal ultrasound scanning includes 3D assessment of the uterine cavity and a basal hormonal profile. * Semen analysis. Ovarian stimulation: * Will be on day 2 or 3 of the menstrual cycle * Using rFSH SC injections with a dose of 150 to 225 IU per day and highly purified hMG with a dose of 75 IU per day. These patients will be divided into two equal groups: Group 1 (Fixed GnRH antagonist protocol) (n= 50): • GnRH antagonist (Cetrotide 0.25 mg) SC injection will be added daily from the 6th day of COH and will be continued till the day of the GnRH agonist trigger. Group 2 (Progesterone-primed ovarian stimulation) (n= 50): • A daily dose of 20 mg dydrogesterone (2 Duphastone 10 mg tablets) will be added from day 1 or 2 of the menstrual cycle till day of trigger

You may qualify if:

• Female age \<37 years.
• Body mass index (BMI) between (≥18 kg/m2 and ≤35 kg/m2).
• Polycystic ovarian syndrome patients (according to Rotterdam criteria).
• Patients suffering from primary or secondary infertility who are candidates for ICSI.

You may not qualify if:

• Uncorrected Uterine factor of infertility: intrauterine adhesions, submucosal fibroids, and septate uterus.
• Severe male factor infertility

Sponsors & Collaborators

• El Shatby University Hospital for Obstetrics and Gynecology: lead

Study Sites (1)

ELShatby University Hospital

Alexandria, Alexandria Governorate, 21648, Egypt

Location

Related Publications (14)

• Lainas 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 BACKGROUND

• Griesinger 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 BACKGROUND

• Al-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 BACKGROUND

• Toftager 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 BACKGROUND

• Depalo 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 BACKGROUND

• Messinis 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 BACKGROUND

• 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.

  PMID: 37143731 BACKGROUND

• Pirtea P, de Ziegler D, Poulain M, Ayoubi JM. New Twists in Ovarian Stimulation and Their Practical Implications. Front Med (Lausanne). 2019 Sep 4;6:197. doi: 10.3389/fmed.2019.00197. eCollection 2019.

  PMID: 31555650 BACKGROUND

• Zhu X, Ye H, Ye J, Fu Y. Progesterone protocol versus gonadotropin-releasing hormone antagonist protocol in women with polycystic ovarian syndrome undergoing in vitro fertilization treatments with frozen-thawed embryo transfer: a prospective randomized controlled trial. Ann Transl Med. 2021 Mar;9(5):387. doi: 10.21037/atm-20-1592.

  PMID: 33842608 BACKGROUND

• Chen ZJ, Shi Y, Sun Y, Zhang B, Liang X, Cao Y, Yang J, Liu J, Wei D, Weng N, Tian L, Hao C, Yang D, Zhou F, Shi J, Xu Y, Li J, Yan J, Qin Y, Zhao H, Zhang H, Legro RS. Fresh versus Frozen Embryos for Infertility in the Polycystic Ovary Syndrome. N Engl J Med. 2016 Aug 11;375(6):523-33. doi: 10.1056/NEJMoa1513873.

  PMID: 27509101 BACKGROUND

• Delvigne A, Rozenberg S. Epidemiology and prevention of ovarian hyperstimulation syndrome (OHSS): a review. Hum Reprod Update. 2002 Nov-Dec;8(6):559-77. doi: 10.1093/humupd/8.6.559.

  PMID: 12498425 BACKGROUND

• Sultan C, Paris F. Clinical expression of polycystic ovary syndrome in adolescent girls. Fertil Steril. 2006 Jul;86 Suppl 1:S6. doi: 10.1016/j.fertnstert.2006.04.015.

  PMID: 16798287 BACKGROUND

• Thessaloniki ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Consensus on infertility treatment related to polycystic ovary syndrome. Hum Reprod. 2008 Mar;23(3):462-77. doi: 10.1093/humrep/dem426.

  PMID: 18308833 BACKGROUND

• Zhu X, Ye H, Fu Y. The Utrogestan and hMG protocol in patients with polycystic ovarian syndrome undergoing controlled ovarian hyperstimulation during IVF/ICSI treatments. Medicine (Baltimore). 2016 Jul;95(28):e4193. doi: 10.1097/MD.0000000000004193.

  PMID: 27428219 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Progesterone; Dydrogesterone; cetrorelix

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Pregnadienes

Study Officials

• Ismail E Khalifa, Ass.lecturer

  Elshatby University hospital

  PRINCIPAL INVESTIGATOR

• Sherif S Gafaar, Professor

  Elshatby University hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: December 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

EG (1)