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NCT03555942·Not applicable·INTERVENTIONAL

Luteal Phase-start Ovarian Stimulation With Corifollitropin Alfa

GanirelixOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

44

Locations

2

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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 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.

Interventions

Treatment arms and agents.

DRUG

Follicular phase corifollitropin alfa

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

DRUG

Luteal phase corifollitropin alfa

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

Timeline

From registration to results.

  1. First posted

    Jun 14, 2018

  2. Study start

    May 8, 2018

  3. Primary completion

    Nov 30, 2021

  4. Study completion

    Dec 1, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Mar 31, 2022

Outcomes

What the study measures.

Primary outcomes

Mean number of euploid embryos

Time frame · 15-45 days following oocyte retrieval procedure

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

Secondary outcomes

Number of oocytes

Time frame · 9 -20 days from initiation of ovarian stimulation

The outcome will be evaluated on the day of oocyte retrieval

Number of MIIs

Time frame · 9 -20 days from initiation of ovarian stimulation

The outcome will be evaluated on the day of oocyte retrieval

Total additional dose of rFSH (IU)

Time frame · 9 -20 days from initiation of ovarian stimulation

Addition total units of FSH following corifollitropin alfa.The outcome will be evaluated on the day of final oocyte maturation

Duration of ovarian stimulation

Time frame · 9 -20 days from initiation of ovarian stimulation

Total days of ovarian stimulation .The outcome will be evaluated on the day of final oocyte maturation

Endocrine profile at specific intervals

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

Estradiol, LH, FSH, Progesterone

Clinical pregnancy rates following transfer of embryos generated from oocytes from follicular phase vs. luteal phase stimulation

Time frame · 5-8 weeks after embryo transfer procedure

Clinical pregnancy rates , presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
35 Years
Sex
FEMALE
Healthy volunteers
Yes

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)

Study locations

2 registered sites.

Spain. Showing up to 24 locations stored in the fast local snapshot.

Consultorio Dexeus

Barcelona, Spain

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, Spain

Publications

Results and literature.

PMID 36269092 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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