Luteal Phase-start Ovarian Stimulation With Corifollitropin Alfa

Infertility Clinical Trial

Official title:

Follicular or Luteal Start Ovarian Stimulation With Corifollitropin Alfa. A Prospective Equivalence Study With Repeated Ovarian Stimulation in Oocyte Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555942
• Other study ID #: FSD-COR-2017-01
• Status: Completed
• Phase: N/A
• Start date: May 8, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2022
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 1, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Follicular phase corifollitropin alfa
GnRH antagonist protocol with corifollitropin alfa initiated in the follicular phase (day 2 or 3 of the menstrual cycle)
• Luteal phase corifollitropin alfa
GnRH antagonist protocol with corifollitropin alfa initiated in the luteal phase (5 days after an LH peak)

Locations

Country	Name	City	State
Spain	Consultorio Dexeus	Barcelona
Spain	Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Universitari Dexeus

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of oocytes	The outcome will be evaluated on the day of oocyte retrieval	9 -20 days from initiation of ovarian stimulation
Secondary	Number of MIIs	The outcome will be evaluated on the day of oocyte retrieval	9 -20 days from initiation of ovarian stimulation
Secondary	Total additional dose of rFSH (IU)	Addition total units of FSH following corifollitropin alfa.The outcome will be evaluated on the day of final oocyte maturation	9 -20 days from initiation of ovarian stimulation
Secondary	Duration of ovarian stimulation	Total days of ovarian stimulation .The outcome will be evaluated on the day of final oocyte maturation	9 -20 days from initiation of ovarian stimulation
Secondary	Endocrine profile at specific intervals	Estradiol, LH, FSH, Progesterone	Stimulation day 1, day 6, day 8, and Day of final oocyte maturation (actual day may vary between 9-15)
Secondary	Clinical pregnancy rates following transfer of embryos generated from oocytes from follicular phase vs. luteal phase stimulation	Clinical pregnancy rates , presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity	5-8 weeks after embryo transfer procedure