Supplementation With Human Chorionic Gonadotropin (hCG) During Controlled Ovarian Stimulation With Recombinant Follicle-stimulating Hormone (FSH) for In Vitro Fertilisation

August 3, 2010 updated by: Rigshospitalet, Denmark

Supplementation With hCG During Controlled Ovarian Stimulation With Recombinant FSH for in Vitro Fertilisation. A Randomized Controlled Clinical Study. Clinical, Embryological, Endocrine and Genetic Aspects.

The purpose of this trial is to study whether addition of different doses of human chorionic gonadotropins during controlled ovarian stimulation for patients undergoing IVF will improve the number of top-quality embryos.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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 Locations

  • Denmark
      • Copenhagen, Denmark, KBH O
        • The Fertility Clinic, Rigshospitalet

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

25 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Females with indication for COS and IVF;
  2. Age between 25-37 years;
  3. BMI >18 and < 30 kg/m2;
  4. A regular menstrual cycle between 24 and 35 days and presumed to be ovulatory;
  5. Two ovaries;
  6. Tubal or unexplained infertility, including endometriosis stage I/II;
  7. A uterus consistent with expected normal function (e.g. no clinically interfering uterine fibroids) documented by transvaginal ultrasound at the screening;
  8. Male partner with sperm quality compatible with fertilization via IVF procedure or previous clinical pregnancy;
  9. Early follicular phase serum FSH levels of 1-12 IU/l;
  10. Early follicular phase total antral follicle (2-10mm) count ≥ 6;
  11. Confirmation of down-regulation before randomisation by transvaginal ultrasound;
  12. Willing and able to sign informed consent.

Exclusion Criteria:

  1. History of or current PCOS, endometriosis stage III/IV or severe male factor requiring ICSI;
  2. History of severe ovarian hyperstimulation syndrome (OHSS);
  3. Presence of unilateral or bilateral hydrosalpinx at ultrasound;
  4. More than three previously COS cycles;
  5. Previous poor response on an IVF-cycle, defined as >20 days of gonadotrophin stimulation, cancellation due to limited follicular response or less than four follicles of ³15 mm diameter;
  6. Previous IVF cycle with unsuccessful fertilization, defined as fertilisation of £20% of the retrieved oocytes;
  7. History of recurrent miscarriage;
  8. FSH>12IU/L or LH>12UI/L (early follicular phase);
  9. Contraindications for the use of gonadotropins or GnRH analogues;
  10. Recent history of current epilepsy, HIV infection, diabetes or cardiovascular gastrointestinal, hepatic, renal or pulmonary disease;
  11. Pregnancy, lactation or contraindication to pregnancy;
  12. Current past (last 12 months) abuse of alcohol or drugs;
  13. History of chemotherapy (except for gestational conditions) of radiotherapy;
  14. Undiagnosed vaginal bleeding;
  15. Tumours of the ovary, breast, adrenal gland, pituitary or hypothalamus and malformation of sexual organs incompatible with pregnancy;
  16. Abnormal karyotyping of the patient (if karyotyping is performed);
  17. Hypersensitivity to any trial product.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control arm
150 iu/day of rFSH alone
Drug: rFSH
150 iu/day of rFSH
Experimental: hCG low dose
150 iu/day of rFSH + 50 iu/day of hCG from stimulation day 1
Drug: rFSH
150 iu/day of rFSH
Drug: human chorionic gonadotropin
50 iu/day of hCG from stimulation day 1
Drug: human chorionic gonadotropin
100 iu/day of hCG from stimulation day 1
Drug: human chorionic gonadotropin
150 iu/day of hCG from stimulation day 1
Experimental: hCG medium dose
150 iu/day of rFSH + 100 iu/day of hCG from stimulation day 1
Drug: rFSH
150 iu/day of rFSH
Drug: human chorionic gonadotropin
50 iu/day of hCG from stimulation day 1
Drug: human chorionic gonadotropin
100 iu/day of hCG from stimulation day 1
Drug: human chorionic gonadotropin
150 iu/day of hCG from stimulation day 1
Experimental: hCG high dose
150 iu/day of rFSH + 150 iu/day of hCG from stimulation day 1
Drug: rFSH
150 iu/day of rFSH
Drug: human chorionic gonadotropin
50 iu/day of hCG from stimulation day 1
Drug: human chorionic gonadotropin
100 iu/day of hCG from stimulation day 1
Drug: human chorionic gonadotropin
150 iu/day of hCG from stimulation day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Total number of top-quality embryos at day 3

Secondary Outcome Measures

Outcome Measure
Implantation rate; Dose of rFSH needed; Serum levels of endocrine parameters; Ongoing pregnancy; Follicular fluid levels of endocrine parameters and cytokines; Expressions of gene families in granulosa cells and the cumulus complex.

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria

February 13, 2009

First Posted (Estimate)

February 16, 2009

Study Record Updates

Last Update Posted (Estimate)

August 4, 2010

Last Update Submitted That Met QC Criteria

August 3, 2010

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-257

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.

Clinical Trials on Infertility

Clinical Trials on rFSH

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe