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

IVI Madrid

Status and phase: Terminated; Phase 4

Conditions: Infertility

Treatments: Drug: Corifollitropin alfa

Study type: Interventional

Funder types: Other

Identifiers

NCT02402192

1411-MAD-079-CB

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 3 patient groups

Corifollitropin alfa

Active Comparator group

Description:

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.

Treatment:

Drug: Corifollitropin alfa

recombinant FSH

Active Comparator group

Description:

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.

Treatment:

Drug: Corifollitropin alfa

HP- hMG

Active Comparator group

Description:

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 .

Treatment:

Drug: Corifollitropin alfa