The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.

June 9, 2006 updated by: Central Jutland Regional Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Skive, Denmark, 7800
        • Recruiting
        • Fertilitetsklinikken Sygehus Viborg
        • Contact:
        • Principal Investigator:
          • Peter Humaidan, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Circulatory levels of Estradiol on the day of hCG

Secondary Outcome Measures

Outcome Measure
embryo quality
Clinical pregnancy rate
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
Ongoing pregnancy rate
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Jutland Regional Hospital

Investigators

  • Principal Investigator: Peter Humaidan, M.D., Fertilitetsklinikken Sygehus Viborg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Registration Dates

First Submitted

June 6, 2006

First Submitted That Met QC Criteria

June 6, 2006

First Posted (ESTIMATE)

June 7, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2006

Last Update Submitted That Met QC Criteria

June 9, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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