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

Infertility Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844311
• Other study ID #: 2008-257
• Status: Completed
• Phase: Phase 4
• First received: February 13, 2009
• Last updated: August 3, 2010
• Start date: February 2009
• Est. completion date: June 2010

Study information

• Verified date: February 2009
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 37 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• rFSH
150 iu/day of rFSH
• human chorionic gonadotropin
50 iu/day of hCG from stimulation day 1
• human chorionic gonadotropin
100 iu/day of hCG from stimulation day 1
• human chorionic gonadotropin
150 iu/day of hCG from stimulation day 1

Locations

Country	Name	City	State
Denmark	The Fertility Clinic, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of top-quality embryos at day 3
Secondary	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.