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InfertilityNCT03555942

Luteal Phase-start Ovarian Stimulation With Corifollitropin Alfa

A study testing Follicular phase corifollitropin alfa and Luteal phase corifollitropin alfa in people with Infertility, run by Fundacion Dexeus at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility
What is being tested?
Follicular phase corifollitropin alfa and Luteal phase corifollitropin alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesSpain
Study dates
8 May 2018to 1 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • Endometriosis
  • AFC>20
  • PCOS
  • Low ovarian reserve
  • Endocrine abnormalities
  • Hormonal contraception
Show all 9Show fewer
  • Contraindication of hormonal treatment
  • History of Ovarian Hyperstimulation Syndrome or hyper-response (> 30 follicles .
  • 11mm)

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Consultorio Dexeus

    Barcelona, 08028

  • Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

    Barcelona, 08037

Other trials in Spain

About this study

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

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

Read the 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
Being tested
Follicular phase corifollitropin alfa, Luteal phase corifollitropin alfa
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Follicular phase corifollitropin alfaDrug

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

  • Luteal phase corifollitropin alfaDrug

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

Study groups in NCT03555942
Study groupRoleWhat they receive
Early follicular phase protocolActive comparatorOn 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.
Receives: Drug: Follicular phase corifollitropin alfa
Luteal phase protocolExperimentalFollowing 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.
Receives: Drug: Luteal phase corifollitropin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean number of euploid embryos

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

    Measured: 15-45 days following oocyte retrieval procedure

Secondary outcomes (6)

  1. Number of oocytes

    The outcome will be evaluated on the day of oocyte retrieval

    Measured: 9 -20 days from initiation of ovarian stimulation

  2. Number of MIIs

    The outcome will be evaluated on the day of oocyte retrieval

    Measured: 9 -20 days from initiation of ovarian stimulation

  3. 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

    Measured: 9 -20 days from initiation of ovarian stimulation

  4. Duration of ovarian stimulation

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

    Measured: 9 -20 days from initiation of ovarian stimulation

  5. Endocrine profile at specific intervals

    Estradiol, LH, FSH, Progesterone

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

  6. 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

    Measured: 5-8 weeks after embryo transfer procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2018
  2. Study start8 May 2018
  3. Primary completion30 Nov 2021
  4. Study completion1 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Overall, 44 oocyte donors women will be asked to participate in a trial in which they will undergo 2 consecutive ovarian stimulation protocols within a period of 6 months with 150μg corifollitropin alfa followed by 200 IU rFSH in a fixed GnRH antagonist protocol starting in the early follicular, and luteal menstrual cycle phase
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03555942
Sponsor's protocol ID
FSD-COR-2017-01
Status last verified
Mar 2022
First submitted
8 May 2018
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36269092

Questions about this trial

What is this clinical trial studying?

A study testing Follicular phase corifollitropin alfa and Luteal phase corifollitropin alfa in people with Infertility, run by Fundacion Dexeus at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean number of euploid embryos (time frame: 15-45 days following oocyte retrieval procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03555942, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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