Luteal Phase-start Ovarian Stimulation With Corifollitropin Alfa

NCT03555942 | Completed

• 1 other identifier: FSD-COR-2017-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the effect of random-start of ovarian stimulation initiated in the early follicular or luteal phase on the pharmacokinetics and follicular dynamics and embryo euploidy rates in oocyte donors treated with identical ovarian stimulation protocols with corifollitropin alfa and GnRH antagonist pituitary downregulation

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Mean number of euploid embryos

  Number of euploid embryos between oocytes received from follicular phase or luteal phase initiation of ovarian stimulation.

  15-45 days following oocyte retrieval procedure

Secondary Outcomes (6)

• Number of oocytes

  9 -20 days from initiation of ovarian stimulation

• Number of MIIs

  9 -20 days from initiation of ovarian stimulation

• Total additional dose of rFSH (IU)

  9 -20 days from initiation of ovarian stimulation

• Duration of ovarian stimulation

  9 -20 days from initiation of ovarian stimulation

• Endocrine profile at specific intervals

  Stimulation day 1, day 6, day 8, and Day of final oocyte maturation (actual day may vary between 9-15)

Study Arms (2)

Early follicular phase protocol

ACTIVE COMPARATOR

On day 2 or 3 of the menstrual cycle, following baseline blood sampling, a single SC injection of 150 ìg corifollitropin alfa will be administered (Stimulation Day 1). Starting on Stimulation Day 6, the subject will receive a daily SC injection of 0.25 mg ganirelix up to and including the day of GnRH agonist triggering administration to prevent premature LH surges. From Stimulation Day 8 onwards treatment is continued with a daily SC dose of rFSH (200IU/day) up to the day of GnRHa administration.

Drug: Follicular phase corifollitropin alfa

Luteal phase protocol

EXPERIMENTAL

Following baseline blood sampling on cycle day 2 of 3 of the menstrual cycle, patients will be followed up with blood and ultrasound from cycle day 10 onwards till the detection of serum LH peak. LH peak will be defined as an increase in serum LH above 20IU/LH. Five (5) days after the LH peak a single SC injection of 150 ìg corifollitropin alfa will be administered (Stimulation Day 1). Starting on Stimulation Day 6, the subject will receive a daily SC injection of 0.25 mg ganirelix up to and including the day of GnRH agonist triggering administration to prevent premature LH surges. From Stimulation Day 8 onwards treatment is continued with a daily SC dose of rFSH (200IU/day) up to the day of GnRHa administration.

Drug: Luteal phase corifollitropin alfa

Interventions

Follicular phase corifollitropin alfa DRUG

GnRH antagonist protocol with corifollitropin alfa initiated in the follicular phase (day 2 or 3 of the menstrual cycle)

Early follicular phase protocol

Luteal phase corifollitropin alfa DRUG

GnRH antagonist protocol with corifollitropin alfa initiated in the luteal phase (5 days after an LH peak)

Luteal phase protocol

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy eligible oocyte donors
• Age 18-34 years
• AFC \>12 and AMH\>1.5 ng/ml
• BMI 19-28kg/m2
• Body weight \>60kg
• Both ovaries present
• Willing to participate in the study
• Willing to use non-hormonal contraception or not needing contraception Recipients will be eligible only if their partners' sperm which will be used for ICSI will be normal. Couples will be excluded in case of moderate to severe oligoasthenospermia.

You may not qualify if:

• Endometriosis
• AFC\>20
• PCOS
• Low ovarian reserve
• Endocrine abnormalities
• Hormonal contraception
• Contraindication of hormonal treatment
• History of Ovarian Hyperstimulation Syndrome or hyper-response (\> 30 follicles .
• mm)

Sponsors & Collaborators

• Fundacion Dexeus: lead

Study Sites (2)

Consultorio Dexeus

Barcelona, 08028, Spain

Location

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, 08037, Spain

Location

Related Publications (1)

• Martinez F, Clua E, Roca M, Garcia S, Polyzos NP. Comparison of blastocyst euploidy rates following luteal versus follicular phase stimulation in a GnRH antagonist protocol: a prospective study with repeated ovarian stimulation cycles. Hum Reprod. 2022 Nov 24;37(12):2777-2786. doi: 10.1093/humrep/deac222.

  PMID: 36269092 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical and Scientific Director

Model Details: Overall, 44 oocyte donors women will be asked to participate in a trial in which they will undergo 2 consecutive ovarian stimulation protocols within a period of 6 months with 150μg corifollitropin alfa followed by 200 IU rFSH in a fixed GnRH antagonist protocol starting in the early follicular, and luteal menstrual cycle phase

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 14, 2018
• Study Start: May 8, 2018
• Primary Completion: November 30, 2021
• Study Completion: December 1, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

ES (2)