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Completed

NCT Number: NCT03555942

Luteal Phase-start Ovarian Stimulation With Corifollitropin Alfa

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

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Consultorio Dexeus, Barcelona, Spain

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About this study

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:

  • Potentially immediate synchronization of oocyte donors with recipients aiming to fresh oocyte donation.
  • Fertility preservation patients for medical, oncological and non-medical indication
  • Any situation in which endometrial receptivity is not pursued.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 .

11mm)

Treatment and study plan

Follicular phase corifollitropin alfa

Drug

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

Luteal phase corifollitropin alfa

Drug

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

Primary outcomes

  1. 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

  1. Number of oocytes

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

    The outcome will be evaluated on the day of oocyte retrieval

  2. Number of MIIs

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

    The outcome will be evaluated on the day of oocyte retrieval

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Fundacion Dexeus

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2018
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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