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Type of Gonadotropin and Embryo Kinetics of Development

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02402192
Acronym
PEM-ESD
Enrollment
201
Registered
2015-03-30
Start date
2015-04-30
Completion date
2016-12-31
Last updated
2022-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

corifollitropin alfa, recombinant FSH, HP-hMG, time-lapse, kinetics of development

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.

Interventions

DRUGCorifollitropin alfa

Sponsors

IVI Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
T5 defined as the time that embryo needs to reach a 5-cell stage.Baseline

Secondary

MeasureTime frame
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 - ImplantationA month
Levels of estradiol (pg / ml) Number of embryos transferred and cryopreserved - Pregnancy rate - ImplantationA month
Levels of progesterone (ng/ml)A month
Fertilization rateA month
Number of embryos transferred and cryopreservedA month
Length of stimulation (days)a month
Implantation rateA monthe
Miscarriage rateA month
Cancellation rate per cycle initiatedA month
Ovarian hyperstimulation syndrome rateA month
Timings of cellular divisionsA month
Pregnancy rateA month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026