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Completed

NCT Number: NCT02437032

Gonadotropin Type in Ovarian Stimulation

A key challenge facing reproductive biologists is the integration of the knowledge about oocyte-secreted factors into coherent physiological mechanisms of how oocytes govern folliculogenesis, cumulus cell function, and oocyte and embryo development. Although key oocyte-secreted factors have been identified, understanding their modes of action is complicated by multiple interactions between maternal and oocyte signaling molecules, as well as the constantly changing state of physical interactions between the oocyte and its companion somatic cells during folliculogenesis. Thus, the investigators study aimed to determine if there is any relationship between different gonadotropin preparations and oocyte-secreted factor secretion, the endocrine pattern in follicular fluid, and the apoptotic rate in cumulus cells during controlled ovarian stimulation.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

The follicular environment is primarily influenced by the type of gonadotropin the follicle is exposed to during the follicular phase. The role of gonadotropins has been especially important in improving the efficiency of in vitro fertilization. Several studies comparing the use of human menopausal gonadotropin (hMG) with recombinant follicle-stimulating hormone (rFSH) have found significant differences in the endocrinological profile and the follicular dynamics. These differences have been related to the human chorionic gonadotropin (hCG)-driven luteinizing hormone (LH) activity added to hMG. Moreover, differences in the proportion of acid residues in FSH molecules should be considered.

On the other hand, the main physiological regulatory hormones of follicular survival are the gonadotropins. Suppression of serum gonadotropins leads to massive apoptosis of granulosa cells in developing follicles resulting in atresia; whereas, gonadotropin treatment of early antral and pre-ovulatory follicles prevents this unplanned apoptosis. However, studies using cultured rat granulosa cells have shown that treatments with FSH or LH/hCG are ineffective in preventing spontaneous apoptosis, suggesting neighboring theca cells and local factors produced in the ovary are important for regulation of follicle growth and atresia.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-35 years old
  • regular menstrual cycles
  • no hereditary or chromosomal diseases normal karyotype negative for sexually transmitted diseases
  • at least seven antral follicles per ovary

Exclusion criteria

  • PCO

Treatment and study plan

recombinant FSH

Drug

Controlled ovarian stimulation with 150-300 UI recombinant FSH

Other names: Gonal-F

Urinary FSH

Drug

Controlled ovarian stimulation with 150-300 UI urinary FSH

Other names: Fostipur

hMG

Drug

Controlled ovarian stimulation with 150-300 UI hMG

Other names: hMG-Lepori

Primary outcomes

  1. GDF-9 and BMP-15 secretion

    Time frame: 3 years

    To measure GDF-9 (ng/ml) and BMP-15 (micrograms/microliter)

Secondary outcomes

  1. Steroids levels in follicular fluid (estradiol, progesterone, testosterone, FSH)

    Time frame: 3 years

    To measure estradiol (pg/ml), progesterone (ng/ml), FSH (mUI/ml) and testosterone (ng/ml)

  2. Apoptotic rate in cumulus cells

    Time frame: 3 years

    To measure early and late apoptotic rate (%)

Sponsors and collaborators

Lead sponsor

IVI Madrid

Other

Registry information

Official study title

Type of Gonadotropin During Controlled Ovarian Stimulation Affects the Endocrine Profile in Follicular Fluid and Apoptotic Rate in Granulose Cells

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 7, 2015
Registry last updated
May 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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