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

NCT ID: NCT00844311

Last Updated: 2010-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-06-30

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control arm

150 iu/day of rFSH alone

Group Type: ACTIVE_COMPARATOR

rFSH

Intervention Type: DRUG

150 iu/day of rFSH

hCG low dose

150 iu/day of rFSH + 50 iu/day of hCG from stimulation day 1

Group Type: EXPERIMENTAL

rFSH

Intervention Type: DRUG

150 iu/day of rFSH

human chorionic gonadotropin

Intervention Type: DRUG

50 iu/day of hCG from stimulation day 1

hCG medium dose

150 iu/day of rFSH + 100 iu/day of hCG from stimulation day 1

Group Type: EXPERIMENTAL

rFSH

Intervention Type: DRUG

150 iu/day of rFSH

human chorionic gonadotropin

Intervention Type: DRUG

100 iu/day of hCG from stimulation day 1

hCG high dose

150 iu/day of rFSH + 150 iu/day of hCG from stimulation day 1

Group Type: EXPERIMENTAL

rFSH

Intervention Type: DRUG

150 iu/day of rFSH

human chorionic gonadotropin

Intervention Type: DRUG

150 iu/day of hCG from stimulation day 1

Interventions

rFSH

150 iu/day of rFSH

Intervention Type: DRUG

human chorionic gonadotropin

50 iu/day of hCG from stimulation day 1

Intervention Type: DRUG

human chorionic gonadotropin

100 iu/day of hCG from stimulation day 1

Intervention Type: DRUG

human chorionic gonadotropin

150 iu/day of hCG from stimulation day 1

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Locations

The Fertility Clinic, Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

References

Thuesen LL, Andersen AN, Loft A, Smitz J. Intrafollicular endocrine milieu after addition of hCG to recombinant FSH during controlled ovarian stimulation for in vitro fertilization. J Clin Endocrinol Metab. 2014 Feb;99(2):517-26. doi: 10.1210/jc.2013-1528. Epub 2013 Dec 2.

Reference Type: DERIVED

PMID: 24297796 (View on PubMed)

Thuesen LL, Loft A, Egeberg AN, Smitz J, Petersen JH, Andersen AN. A randomized controlled dose-response pilot study of addition of hCG to recombinant FSH during controlled ovarian stimulation for in vitro fertilization. Hum Reprod. 2012 Oct;27(10):3074-84. doi: 10.1093/humrep/des256. Epub 2012 Jul 12.

Reference Type: DERIVED

PMID: 22791754 (View on PubMed)

Other Identifiers

2008-257

Identifier Type: -

Identifier Source: org_study_id