Comparison of Two PPOS Models for Pituitary Suppression

NCT06304220 | Not Yet Recruiting

• 1 other identifier: MedroGestrel
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The scarcity of evidence regarding the interchangeable use of different progestogens poses challenges, particularly in international egg donation and fertility preservation programs where standardizing protocols is crucial for achieving consistent efficacy, efficiency, and safety outcomes. Consequently, there's a pressing need for clinical studies to assess the effects of various progestogens on clinical outcomes in controlled ovarian hyperstimulation cycles. This study, a pioneering effort, aims to compare the effects of two progestogens on oocyte performance, safety, and efficiency in an egg donation program involving young, healthy, normo-responding patients.

Conditions

Infertility, Female; Fertility Disorders

Keywords

Primed-progestin ovarian stimulation protocol; Quality of oocytes; Oocyte yield; Ovarian Sensitivty Index; Controlled ovarian hyperstimulation

Outcome Measures

Primary Outcomes (2)

• Total number of oocytes retrieved from follicular puncture

  The total number of oocytes retrieved from the follicular puncture shall be counted.

  5 months

• Number of mature oocytes (MII) retrieved from follicular puncture

  The number of mature oocytes (MII) recovered from the follicular puncture shall be counted.

  5 months

Secondary Outcomes (3)

• Oocyte quality variables

  5 months

• Ovarian sensitivity index (OSI

  5 months

• Follicles

  5 months

Study Arms (2)

Group DSG: Desogestrel

ACTIVE COMPARATOR

Desogestrel Cerazet® 75 mg/day orally from the first day of controlled ovarian hyperstimulation (COH) until the day of trigger with agonist (GnRH-a).

Drug: Cerazet

Group MPA: Medroxyprogesterone

ACTIVE COMPARATOR

Medroxyprogesterone acetate Progevera® 10 mg/day orally from the first day of controlled ovarian hyperstimulation (COH) until the day of trigger with agonist (GnRH-a).

Drug: Cerazet

Interventions

Cerazet DRUG

Comparation of the utilization of two distinct progestogens for pituitary suppression

Also known as: Progevera

Group DSG: Desogestrel; Group MPA: Medroxyprogesterone

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI of 18-29,9 kg/m2
• Ultrasound count of antral follicles prior to COH ≥ 12 follicles
• Normal karyotype and no active sexually transmitted diseases
• No use of combined hormonal contraceptives one month before COH

You may not qualify if:

• Patients excluded from the egg donation program
• Untreated sexually transmitted diseases, positive serology for HBV, HIV, HCV
• Blood disorders, neurodegenerative/psychiatric diseases, carriers of X-linked genetic diseases, oncological diseases, endometriosis.
• Oligomenorrhea (\<1 menstrual cycle in 3 months)
• Use of combined hormonal contraceptives before COH

Sponsors & Collaborators

• NextFertility: lead
• SINAE SL: collaborator

Study Sites (1)

NextFertility

Valencia, Valencia, 46009, Spain

Location

Related Publications (10)

• La Marca A, Capuzzo M. Use of progestins to inhibit spontaneous ovulation during ovarian stimulation: the beginning of a new era? Reprod Biomed Online. 2019 Aug;39(2):321-331. doi: 10.1016/j.rbmo.2019.03.212. Epub 2019 Mar 29.

  PMID: 31138494 BACKGROUND

• Massin N. New stimulation regimens: endogenous and exogenous progesterone use to block the LH surge during ovarian stimulation for IVF. Hum Reprod Update. 2017 Mar 1;23(2):211-220. doi: 10.1093/humupd/dmw047.

  PMID: 28062551 BACKGROUND

• Martinez F, Rodriguez-Purata J, Clua E, Garcia S, Coroleu B, Polyzos N. Ovarian response in oocyte donation cycles under LH suppression with GnRH antagonist or desogestrel progestin: retrospective and comparative study. Gynecol Endocrinol. 2019 Oct;35(10):884-889. doi: 10.1080/09513590.2019.1604662. Epub 2019 May 12.

  PMID: 31081407 BACKGROUND

• Martinez F, Rodriguez-Purata J, Beatriz Rodriguez D, Clua E, Rodriguez I, Coroleu B. Desogestrel versus antagonist injections for LH suppression in oocyte donation cycles: a crossover study. Gynecol Endocrinol. 2019 Oct;35(10):878-883. doi: 10.1080/09513590.2019.1604661. Epub 2019 May 7.

  PMID: 31062995 BACKGROUND

• Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.

  PMID: 30927417 BACKGROUND

• Phillips A, Hahn DW, Klimek S, McGuire JL. A comparison of the potencies and activities of progestogens used in contraceptives. Contraception. 1987 Aug;36(2):181-92. doi: 10.1016/0010-7824(87)90013-8.

  PMID: 3427965 BACKGROUND

• Mikkelsen AL, Lindenberg S. Morphology of in-vitro matured oocytes: impact on fertility potential and embryo quality. Hum Reprod. 2001 Aug;16(8):1714-8. doi: 10.1093/humrep/16.8.1714.

  PMID: 11473970 BACKGROUND

• Rienzi L, Ubaldi FM, Iacobelli M, Minasi MG, Romano S, Ferrero S, Sapienza F, Baroni E, Litwicka K, Greco E. Significance of metaphase II human oocyte morphology on ICSI outcome. Fertil Steril. 2008 Nov;90(5):1692-700. doi: 10.1016/j.fertnstert.2007.09.024. Epub 2008 Feb 4.

  PMID: 18249393 BACKGROUND

• Kazemi A, Ramezanzadeh F, Nasr-Esfahani MH. The relations between dietary antioxidant vitamins intake and oxidative stress in follicular fluid and ART outcomes. Iran J Reprod Med. 2015 Sep;13(9):533-40.

  PMID: 26568757 BACKGROUND

• Gaskins AJ, Afeiche MC, Wright DL, Toth TL, Williams PL, Gillman MW, Hauser R, Chavarro JE. Dietary folate and reproductive success among women undergoing assisted reproduction. Obstet Gynecol. 2014 Oct;124(4):801-809. doi: 10.1097/AOG.0000000000000477.

  PMID: 25198264 BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Luis Quintero

  NextFertility

  STUDY CHAIR

Central Study Contacts

Luis Quintero

CONTACT

+34 963160240; luis.quintero@next-clinics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, and controlled clinical study with two different progestogens: desogestrel 75 mg and medroxyprogesterone acetate 10 mg.

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 12, 2024
• Study Start: July 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

ES (1)