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

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00844311
First received: February 13, 2009
Last updated: August 3, 2010
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: rFSH
Drug: human chorionic gonadotropin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Total number of top-quality embryos at day 3

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 60
Study Start Date: February 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
100 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
150 iu/day of hCG from stimulation day 1

  Eligibility

Ages Eligible for Study:   25 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844311

Locations
Denmark
The Fertility Clinic, Rigshospitalet
Copenhagen, Denmark, KBH O
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00844311     History of Changes
Other Study ID Numbers: 2008-257
Study First Received: February 13, 2009
Last Updated: August 3, 2010
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:
hCG
human chorionic gonadotropin

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Follicle Stimulating Hormone
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 29, 2014