Type of Gonadotropin and Embryo Kinetics of Development (PEM-ESD)

August 9, 2022 updated by: Juan A Garcia-Velasco, IVI Madrid

A Prospective Randomized Trial to Analyze the Effect of the Gonadotropin Administered During Control Ovarian Stimulation on Embryo Kinetics of Development

The study is proposed to determine the effect of three types of gonadotropins that are currently used in protocols of controlled ovarian stimulation in women undergoing in vitro fertilization techniques on the kinetics of embryonic development.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women <38 years old
  • Weight <60 kg
  • Own oocytes
  • Patients have to provide signed informed consent

Exclusion Criteria:

  • Oocyte donors
  • Vitrified oocytes
  • Severe male factor (<1 million spz/ml)
  • Weight >60 kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Corifollitropin alfa
Under current practice, 67 participants will be stimulated with a single injection of 100 mg, sc of Corifollitropin alpha (Elonva®). From day 6 stimulation and even prior to induction of ovulation day, 0.25 mg / day was administered sc ganirelix (Orgalutran®). From day 8 stimulation and depending on the ovarian response, you can add recombinant FSH (Puregon) up to 150 IU by Puregon Pen® device. In the presence of 3 or more follicles ≥17 mm, ovulation is induced with a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) if there is no risk of OHSS, and 36 hours later he held the follicular puncture oocyte retrieval.
Drug: Corifollitropin alfa
Other Names:
  • Elonva
Active Comparator: recombinant FSH
Under current practice, 67 participants will be stimulated with a daily dose of recombinant FSH. Administration of recombinant FSH (Puregon) starts at an initial dose of 150-225 IU / day by the Puregon Pen® device. From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of recombinant FSH according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg or Decapeptyl hCG 6500u (Ovitrelle) is given if there is no risk of OHSS, and 36 hours then held follicular puncture for recovering oocytes.
Drug: Corifollitropin alfa
Other Names:
  • Elonva
Active Comparator: HP- hMG
Under current practice, 67 participants will be stimulated with HP-hMG, following the same pattern described for the group of recombinant FSH. In this case, the initial dose is 225-300 IU / day of HP-hMG (Menopur®). From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of HP-hMG according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) is given if there is no risk of OHSS and 36 hours then held the follicular puncture for oocyte retrieval .
Drug: Corifollitropin alfa
Other Names:
  • Elonva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
T5 defined as the time that embryo needs to reach a 5-cell stage.
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of stimulation (days)
Time Frame: a month
a month
Total dose of gonadotropins (IU)
Time Frame: A month
A month
Levels of FSH (IU) Levels of estradiol (pg / ml) - Levels of progesterone (ng / ml) - Fertilization rate - Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation
Time Frame: A month
A month
Levels of estradiol (pg / ml) Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation
Time Frame: A month
A month
Levels of progesterone (ng/ml)
Time Frame: A month
A month
Fertilization rate
Time Frame: A month
A month
Number of embryos transferred and cryopreserved
Time Frame: A month
A month
Pregnancy rate
Time Frame: A month
A month
Implantation rate
Time Frame: A monthe
A monthe
Miscarriage rate
Time Frame: A month
A month
Cancellation rate per cycle initiated
Time Frame: A month
A month
Ovarian hyperstimulation syndrome rate
Time Frame: A month
A month
Timings of cellular divisions
Time Frame: A month
A month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVI Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Actual)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1411-MAD-079-CB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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