The Effect of LH-Priming During Early Follicular Phase on Ovarian Response and Pregnancy Outcome in GnRHa Down-Regulated Women, Stimulated With Exogenous Gonadotrophins in IVF Treatment

Central Jutland Regional Hospital1 site in 1 country150 target enrollmentApril 2006

ConditionsInfertility

DrugsMENOPUR; GONAL-F

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Infertility
Sponsor: Central Jutland Regional Hospital
Enrollment: 150
Locations: 1
Primary Endpoint: Circulatory levels of Estradiol on the day of hCG
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the effect of LH-activity supplementation during the early follicular phase in GnRHa down-regulated women undergoing IVF in terms of S-Estradiol levels on hCG day by comparing different combinations with HP-HMG and r-FSH.

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

TBD

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Central Jutland Regional Hospital

Eligibility Criteria

Inclusion Criteria

•Females between the ages of 18- 38 years (both included) at the time of randomisation
•Patients for whom treatment with gonadotrophins and GnRH agonist (long protocol) in IVF setting is considered appropriate according to the criteria of the participating centre
•Infertility for at least 1 year before randomisation (except for tubal infertility)
•A maximum of two previous consecutive unsuccessful IVF cycles (i.e. not resulting in an ongoing pregnancy
•25- 34 days of menstruation cycle
•Body mass index (BMI) \< 29 kg/m2

Exclusion Criteria

•Any clinically significant systemic disease (e.g., insulin dependent diabetes)
•Endocrine or metabolic abnormalities (pituitary, adrenal, thyroid, pancreas, liver, or kidney) which can compromise participation in the study
•Any concomitant medications that would interfere with evaluation of study medications. Specifically, any non-study hormonal therapy (except for thyroid medication), prostaglandin inhibitors (NSAIDs, including aspirin) and psychotropic agents (phenothiazine's, major tranquillisers) at the time of study entry. Note: these medications are disallowed for the study duration.
•Presence of clinically significant uterine fibroids
•Undiagnosed vaginal bleeding
•Tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
•Pregnancy, lactation or contraindication to pregnancy - must be confirmed by negative urinary pregnancy test at randomisation

Outcomes

Primary Outcomes

Circulatory levels of Estradiol on the day of hCG

Secondary Outcomes

Total number of follicles as well as the numbers of follicles <10mm, 10-14 mm, >14mm day during gonadotrophin treatment and at the end of stimulation prior to hCG injection
E2 per follicle >14 mm
Total number of oocytes retrieved
fertilization rate
serum hCG > 10 IU/l on day 12-14 after embryo transfer
implantation rate
transferable embryos
Clinical pregnancy rate
Ongoing pregnancy rate
embryo quality
Serum; LH, FSH, Androstenedione, Progesterone, hCG and Inhibin-B. Progesterone seven days after ET day
Intra follicular levels of; endocrine parameters
Endometrial thickness; hCG day (minus 0-2 days)
Total gonadotrophin dose administered