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Gonadotropin Type in Ovarian Stimulation

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02437032
Enrollment
100
Registered
2015-05-07
Start date
2009-04-30
Completion date
2012-12-31
Last updated
2015-05-07

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

Conditions

Infertility

Keywords

GDF-9, BMP-15, Steroids, Apoptosis rate, Endocrinology

Brief summary

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.

Detailed description

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.

Interventions

Controlled ovarian stimulation with 150-300 UI recombinant FSH

Controlled ovarian stimulation with 150-300 UI urinary FSH

DRUGhMG

Controlled ovarian stimulation with 150-300 UI hMG

Sponsors

IVI Madrid
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
GDF-9 and BMP-15 secretion3 yearsTo measure GDF-9 (ng/ml) and BMP-15 (micrograms/microliter)

Secondary

MeasureTime frameDescription
Steroids levels in follicular fluid (estradiol, progesterone, testosterone, FSH)3 yearsTo measure estradiol (pg/ml), progesterone (ng/ml), FSH (mUI/ml) and testosterone (ng/ml)
Apoptotic rate in cumulus cells3 yearsTo measure early and late apoptotic rate (%)

Outcome results

None listed

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