Supplementation With Human Chorionic Gonadotropin (hCG) During Controlled Ovarian Stimulation With Recombinant Follicle-stimulating Hormone (FSH) for In Vitro Fertilisation
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.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 13, 2009
CompletedFirst Posted
Study publicly available on registry
February 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedAugust 4, 2010
February 1, 2009
1.3 years
February 13, 2009
August 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total number of top-quality embryos at day 3
Secondary Outcomes (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.
Study Arms (4)
Control arm
ACTIVE COMPARATOR150 iu/day of rFSH alone
hCG low dose
EXPERIMENTAL150 iu/day of rFSH + 50 iu/day of hCG from stimulation day 1
hCG medium dose
EXPERIMENTAL150 iu/day of rFSH + 100 iu/day of hCG from stimulation day 1
hCG high dose
EXPERIMENTAL150 iu/day of rFSH + 150 iu/day of hCG from stimulation day 1
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Fertility Clinic, Rigshospitalet
Copenhagen, KBH O, Denmark
Related Publications (2)
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.
PMID: 24297796DERIVEDThuesen 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.
PMID: 22791754DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 13, 2009
First Posted
February 16, 2009
Study Start
February 1, 2009
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
August 4, 2010
Record last verified: 2009-02