Supplementation With Human Chorionic Gonadotropin (hCG) During Controlled Ovarian Stimulation With Recombinant Follicle-stimulating Hormone (FSH) for In Vitro Fertilisation
- Registration Number
- NCT00844311
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
- Females with indication for COS and IVF;
- Age between 25-37 years;
- BMI >18 and < 30 kg/m2;
- A regular menstrual cycle between 24 and 35 days and presumed to be ovulatory;
- Two ovaries;
- Tubal or unexplained infertility, including endometriosis stage I/II;
- A uterus consistent with expected normal function (e.g. no clinically interfering uterine fibroids) documented by transvaginal ultrasound at the screening;
- Male partner with sperm quality compatible with fertilization via IVF procedure or previous clinical pregnancy;
- Early follicular phase serum FSH levels of 1-12 IU/l;
- Early follicular phase total antral follicle (2-10mm) count ≥ 6;
- Confirmation of down-regulation before randomisation by transvaginal ultrasound;
- Willing and able to sign informed consent.
Exclusion Criteria
- History of or current PCOS, endometriosis stage III/IV or severe male factor requiring ICSI;
- History of severe ovarian hyperstimulation syndrome (OHSS);
- Presence of unilateral or bilateral hydrosalpinx at ultrasound;
- More than three previously COS cycles;
- 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;
- Previous IVF cycle with unsuccessful fertilization, defined as fertilisation of £20% of the retrieved oocytes;
- History of recurrent miscarriage;
- FSH>12IU/L or LH>12UI/L (early follicular phase);
- Contraindications for the use of gonadotropins or GnRH analogues;
- Recent history of current epilepsy, HIV infection, diabetes or cardiovascular gastrointestinal, hepatic, renal or pulmonary disease;
- Pregnancy, lactation or contraindication to pregnancy;
- Current past (last 12 months) abuse of alcohol or drugs;
- History of chemotherapy (except for gestational conditions) of radiotherapy;
- Undiagnosed vaginal bleeding;
- Tumours of the ovary, breast, adrenal gland, pituitary or hypothalamus and malformation of sexual organs incompatible with pregnancy;
- Abnormal karyotyping of the patient (if karyotyping is performed);
- Hypersensitivity to any trial product.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control arm rFSH 150 iu/day of rFSH alone hCG low dose rFSH 150 iu/day of rFSH + 50 iu/day of hCG from stimulation day 1 hCG medium dose rFSH 150 iu/day of rFSH + 100 iu/day of hCG from stimulation day 1 hCG medium dose human chorionic gonadotropin 150 iu/day of rFSH + 100 iu/day of hCG from stimulation day 1 hCG high dose rFSH 150 iu/day of rFSH + 150 iu/day of hCG from stimulation day 1 hCG low dose human chorionic gonadotropin 150 iu/day of rFSH + 50 iu/day of hCG from stimulation day 1 hCG high dose human chorionic gonadotropin 150 iu/day of rFSH + 150 iu/day of hCG from stimulation day 1
- Primary Outcome Measures
Name Time Method Total number of top-quality embryos at day 3
- Secondary Outcome Measures
Name Time Method 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.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie hCG supplementation in improving embryo quality during IVF?
How does hCG supplementation compare to standard FSH-only protocols in IVC outcomes for infertility patients?
Which biomarkers correlate with response to hCG-FSH combination therapy in controlled ovarian stimulation?
What are the potential adverse events associated with hCG supplementation in IVF cycles and their management?
Are there alternative gonadotropin combinations to rFSH and hCG for optimizing embryo development in infertility treatment?
Trial Locations
- Locations (1)
The Fertility Clinic, Rigshospitalet
🇩🇰Copenhagen, Denmark
The Fertility Clinic, Rigshospitalet🇩🇰Copenhagen, Denmark