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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT00844311
Collaborator
(none)
60
Enrollment
1
Location
4
Arms
15.9
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: rFSH
  • Drug: human chorionic gonadotropin
  • Drug: human chorionic gonadotropin
  • Drug: human chorionic gonadotropin
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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.
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

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
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

Outcome Measures

Primary Outcome Measures

  1. Total number of top-quality embryos at day 3 []

Secondary Outcome Measures

  1. 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. []

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 The Fertility Clinic, Rigshospitalet Copenhagen Denmark KBH O

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00844311
Other Study ID Numbers:
  • 2008-257
First Posted:
Feb 16, 2009
Last Update Posted:
Aug 4, 2010
Last Verified:
Feb 1, 2009
Keywords provided by , ,
hCG
human chorionic gonadotropin
Additional relevant MeSH terms:
Infertility
Chorionic Gonadotropin

Study Results

No Results Posted as of Aug 4, 2010