Luteal Phase-start Ovarian Stimulation With Corifollitropin Alfa

Institut Universitari Dexeus

Status: Completed

Conditions: Infertility

Treatments: Drug: Luteal phase corifollitropin alfa; Drug: Follicular phase corifollitropin alfa

Study type: Interventional

Funder types: Other

Identifiers

NCT03555942

FSD-COR-2017-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Early follicular phase protocol

Active Comparator group

Description:

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.

Treatment:

Drug: Follicular phase corifollitropin alfa

Luteal phase protocol

Experimental group

Description:

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.

Treatment:

Drug: Luteal phase corifollitropin alfa