Ovarian Stimulation With FSH Alone Versus FSH Plus GnRH Antagonist in an Oocyte Donor/Recipient Programme

NCT05759871 | Unknown Phase 1

• 1 other identifier: Non-anta-D
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to compare the efficacy of a protocol using FSH alone with that of a protocol using FSH plus a GnRH antagonist for controlled ovarian hyperstimulation in cycles of elective freezing in the context of a donor/recipient programme.

Conditions

Premature Luteinisation; Progesterone Elevation

Keywords

Controlled ovarian stimulation; GnRH antagonist; oocyte donation; LH surge

Outcome Measures

Primary Outcomes (2)

• Rate of LH secretory peaks

  A secretory peak of LH is defined as the increase at levels ≥10 IU/l.

  3 weeks after start of ovarian stimulation.

• Rate of concentration of progesterone >1 ng/ml

  Concentration of progesterone elevation \>1 ng/ml

  At any time within 3 weeks after start of ovarian stimulation.

Secondary Outcomes (2)

• Rate of ongoing clinical pregnancy

  12 weeks after last menstrual period

• Rate of miscarriage

  Within 20 weeks after last menstrual period

Other Outcomes (2)

• Total dose of gonadotrophins (rFSH)

  2 weeks after last menstrual period

• Number of retrieved cumulus oocytes complexes (COCs)

  3 weeks after last menstrual period / and start of ovarian stimulation

Study Arms (2)

FSH only (no GnRH antagonist)

EXPERIMENTAL

Women receive only FSH starting on day 2 of the cycle. The starting dose of FSH is 225-300 IU s.c. for the first 4 days adjusted thereafter according to the ovarian response.

Other: GnRH antagonist

FSH + GnRH antagonist

ACTIVE COMPARATOR

Women receive 225-300 IU s.c. FSH, and a GnRH antagonist from day 6 of FSH treatment at the dose of 0.25 mg per day until the triggering day. The GnRH antagonist in group 2 is injected each time immediately after the injection of FSH.

Other: GnRH antagonist

Interventions

GnRH antagonist OTHER

The GnRH antagonist in the control group (standard therapy) is administered from day 6 of FSH treatment at the dose of 0.25 mg per day until the triggering day and is injected each time immediately after the injection of FSH.

FSH + GnRH antagonist; FSH only (no GnRH antagonist)

Eligibility Criteria

• Age: 21 Years - 32 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy women 21-32 years old with a BMI of 21 to 29 kg/m2 who wish to donate their oocytes
• normal ovarian reserve tests
• normal menstrual cycles of 26-32 days
• the women would not have received any hormonal treatment during the last three months before entering the study.
• absence of coagulation and/or autoimmune disorders.

You may not qualify if:

• Use of other protocols towards oocyte retrieval, such as natural, or modified natural cycles
• Poor ovarian response according to the Bologna criteria \[22\],
• History of endocrine or metabolic disorders, ovarian cystectomy or oophorectomy,
• Women with the diagnosis of polycystic ovary syndrome
• Clinical and/or laboratory markers of hereditary or acquired thrombophilia that complied to the standard protocols of each Unit.
• Non-hormonal medication for a serious medical condition

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece: collaborator
• Embryoland, Athens, Greece: collaborator
• Embryolab IVF Unit, Thessaloniki, Greece: collaborator
• Assisting Nature IVF Unit, Thessaloniki, Greece: collaborator
• HYGEIA IVF - Embryogenesis A.R.T. Unit, Athens, Greece: collaborator
• Institute of Fertility, Athens, Greece: collaborator
• Mitosis IVF Centre, Pireas, Greece: collaborator

Related Publications (5)

• Wang HL, Lai HH, Chuang TH, Shih YW, Huang SC, Lee MJ, Chen SU. A Patient Friendly Corifollitropin Alfa Protocol without Routine Pituitary Suppression in Normal Responders. PLoS One. 2016 Apr 21;11(4):e0154123. doi: 10.1371/journal.pone.0154123. eCollection 2016.

  PMID: 27100388 BACKGROUND

• Zhang Y, Xu Y, Yu J, Wang X, Xue Q, Shang J, Yang X, Shan X. A premature luteinizing hormone surge without elevated progesterone levels has no adverse effect on cumulative live birth rate in patient undergoing a flexible GnRH antagonist protocol: a retrospective study. J Ovarian Res. 2023 Jun 27;16(1):119. doi: 10.1186/s13048-023-01219-w.

  PMID: 37370146 BACKGROUND

• Kuang Y, Chen Q, Fu Y, Wang Y, Hong Q, Lyu Q, Ai A, Shoham Z. Medroxyprogesterone acetate is an effective oral alternative for preventing premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation for in vitro fertilization. Fertil Steril. 2015 Jul;104(1):62-70.e3. doi: 10.1016/j.fertnstert.2015.03.022. Epub 2015 May 5.

  PMID: 25956370 BACKGROUND

• Messinis IE, Messini CI, Anifandis G, Daponte A. Exogenous progesterone for LH surge prevention is redundant in ovarian stimulation protocols. Reprod Biomed Online. 2021 Apr;42(4):694-697. doi: 10.1016/j.rbmo.2021.01.017. Epub 2021 Jan 30.

  PMID: 33583700 BACKGROUND

• Messinis IE, Templeton A, Baird DT. Endogenous luteinizing hormone surge in women during induction of multiple follicular development with pulsatile follicle stimulating hormone. Clin Endocrinol (Oxf). 1986 Feb;24(2):193-201. doi: 10.1111/j.1365-2265.1986.tb00762.x.

  PMID: 3085995 BACKGROUND

MeSH Terms

Interventions

LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-

Central Study Contacts

Ioannis Messinis, Prof

CONTACT

6944370627; messinis.io@gmail.com

Charalampos Siristatidis, Prof

CONTACT

2107286306; harrysiri@yahoo.gr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Obstetrics - Gynecology & Reproductive Medicine

Model Details: Protocol using FSH alone with that of a protocol using FSH plus a GnRH antagonist for controlled ovarian hyperstimulation in cycles of elective freezing in the context of a donor/recipient programme.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 8, 2023
• Study Start: April 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 10, 2023

Record last verified: 2023-02