Luteal Phase-start Ovarian Stimulation With Corifollitropin Alfa

NCT ID: NCT03555942

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-08
• Study Completion Date: 2021-12-01

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

Detailed Description

The scope of the current prospective trial is to investigate whether Luteal Stimulation (LS) results in equivalent euploid embryos with Follicular Stimulation (FS) in young reproductive age women. The use of the "oocyte donor model" allows extrapolation of the results and application of LS routinely not only in healthy women undergoing fertility preservation but also in all patients irrespective of the menstrual date. This may indeed allow widespread introduction of LS in IVF programs which may result in proper scheduling of ovarian stimulation which is a major issue in everyday clinical practice.

Given that the pharmacokinetics and follicular dynamics of 150μg corifollitropin alfa for luteal stimulation has never been evaluated, the current study of luteal stimulation with corifollitropin alfa could be very interesting for several reasons:

1. Potentially immediate synchronization of oocyte donors with recipients aiming to fresh oocyte donation.

2. Fertility preservation patients for medical, oncological and non-medical indication

3. Any situation in which endometrial receptivity is not pursued.

Conditions

Infertility

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early follicular phase protocol

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.

Group Type: ACTIVE_COMPARATOR

Follicular phase corifollitropin alfa

Intervention Type: DRUG

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

Luteal phase protocol

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.

Group Type: EXPERIMENTAL

Luteal phase corifollitropin alfa

Intervention Type: DRUG

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

Interventions

Follicular phase corifollitropin alfa

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

Intervention Type: DRUG

Luteal phase corifollitropin alfa

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy eligible oocyte donors

2. Age 18-34 years

3. AFC >12 and AMH>1.5 ng/ml

4. BMI 19-28kg/m2

5. Body weight >60kg

6. Both ovaries present

7. Willing to participate in the study

8. 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.

Exclusion Criteria

1. Endometriosis

2. AFC>20

3. PCOS

4. Low ovarian reserve

5. Endocrine abnormalities

6. Hormonal contraception

7. Contraindication of hormonal treatment

8. History of Ovarian Hyperstimulation Syndrome or hyper-response (> 30 follicles .

11mm)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundacion Dexeus

OTHER

Sponsor Role: lead

Responsible Party

Nikolaos Polyzos

Clinical and Scientific Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Consultorio Dexeus

Barcelona, , Spain

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 36269092 (View on PubMed)

Other Identifiers

FSD-COR-2017-01

Identifier Type: -

Identifier Source: org_study_id