Type of Gonadotropin and Embryo Kinetics of Development

Phase 4

Terminated

• Conditions: Infertility
• Interventions: Drug: Corifollitropin alfa

• Registration Number: NCT02402192
• Lead Sponsor: IVI Madrid

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-30
• Study Start: 2015-04
• Primary Completion: 2015-09
• Study Completion: 2016-12
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 201

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corifollitropin alfa	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.
recombinant FSH	Corifollitropin alfa	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.
HP- hMG	Corifollitropin alfa	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 .

Primary Outcome Measures

Name	Time	Method
T5 defined as the time that embryo needs to reach a 5-cell stage.	Baseline

Secondary Outcome Measures

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