A Study to Evaluate the Baseline Follicle Stimulating Hormone, Ovarian Volume and Antral Follicle Count as Prognostic Factors of the Outcome of In-vitro Fertilisation/Intracytosolic Sperm Injection in Infertile Patients Receiving Gonal f for Controlled Ovarian Hyperstimulation

Sponsor

Merck KGaA, Darmstadt, Germany (Industry)

Overall Status

Completed

CT.gov ID

NCT01196143

Collaborator

(none)

356

Enrollment

Location

Duration (Months)

13.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase IV non-interventional, multicentric observational study to evaluate the baseline follicle stimulating hormone (FSH) levels, ovarian volume, antral follicle count (AFC) and age as prognostic factors of the outcome of the in-vitro fertilisation/intracytosolic sperm injection (IVF/ICSI) in infertile subjects receiving Gonal-f for controlled ovarian hyperstimulation (COH).

Condition or Disease	Intervention/Treatment	Phase
Infertility

Detailed Description

Treatment of subfertility and infertility by assisted reproduction technologies (ART) such as IVF and embryo transfer (ET) requires multiple follicular development to increase the number of female gametes, and the chances of a successful treatment outcome. These technologies include the stimulation of multiple follicular development by exogenous FSH administration and the suppression of endogenous luteinizing hormone (LH) secretion by administration of a GnRH analogue (antagonist or agonist, as required). A single dose of human chorionic gonadotropin (hCG) is administered to mimic the endogenous LH surge and induce final oocyte maturation after adequate follicular development. Recombinant-hFSH (r-hFSH) has been shown to be efficacious in terms of number of oocytes recovered and in terms of pregnancy rates as compared to urinary-hFSH.

Gonal-f fill-by-mass is available as a liquid formulation that can be administered with the pen device. The pen device is prefilled and hence the subject does not require to assemble the device making it simpler to use. The prefilled pen allows the accurate delivery of a precise dose of r-hFSH in 37.5 International Units (IU) increments.

OBJECTIVES

Primary objective:

Evaluation of the significance of baseline FSH, ovarian volume and AFC with a model adjusted for age as prognostic factors of the IVF/ICSI treatment outcome.

This study planned to enrol 500 female subjects undergoing COH for IVF/ICSI-treatment with Gonal-f. Gonal-f will be administered daily subcutaneously (s.c.) according to the centre's usual clinical practice, commencing on Days 2 or 3 of the cycle during the stimulation period. Treatment with Gonal-f will be continued until adequate follicular development has been achieved with the dose adjusted according to the subject's response, to usually not higher than 450 IU daily. A single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG would be administered 24-48 hours after the last Gonal-f injection to induce final follicular maturation. Gonal-f will be started approximately 2 weeks after the start of an gonadotrophin-releasing hormone (GnRH) agonist treatment, both being continued until adequate follicular development will be achieved. Oocyte retrieval will be done 34-36 hours after hCG administration followed by IVF/ICSI treatment according to clinic's protocol. Each enrolled subject would be followed up until the confirmation of her pregnancy status. Active follow up of all pregnancies will be performed, including those subjects withdrawn from the study.

Study Design

Study Type:

Observational

Actual Enrollment :

356 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Non-interventional Observational Study to Evaluate the Baseline FSH, Ovarian Volume and AFC (Antral Follicle Count) as Prognostic Factors of the Outcome of the In-vitro Fertilization/Intracytosolic Sperm Injection (IVF/ICSI) in Infertile Patients Who Receive r-FSH (GONAL-f®) for Controlled Ovarian Hyperstimulation

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Outcome Measures

Primary Outcome Measures

Live birth rate [Up to 28 days after birth]

Secondary Outcome Measures

Pregnancy rate (ongoing, clinical, biochemical) [up to 40 weeks post embryo-transfer]
Biochemical: up to 2 weeks post embryo-transfer / clinical: up to 12 weeks post embryo-transfer / ongoing: up to 40 weeks post embryo-transfer
Fertilization rate [24 hours post oocyte retrieval]
Implantation rate [2 weeks post embryo-transfer]
Detailed record of adverse events [Up to 1 year after subject enrollment]
Hormone (E2) levels on hCG day [Up to 12 hours prior to hCG administration]
Duration of treatment [Up to 12 hours post last FSH injection]
Total amount of FSH administered [Up to 1 hour post last FSH injection]
Number of oocytes [Up to 1 hour post oocyte retrieval]
Miscarriage rate [Up to 12 weeks post embryo-transfer]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 43 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Pre-menopausal female subjects aged between 20-43 years
Subjects requiring treatment with recombinant FSH for COH for IVF and/or ICSI
Subjects who are able to communicate well with the investigator and can comply with the requirements of the entire study
Subjects who have given written informed consent, prior to treatment, with the understanding that consent may be withdrawn by the subject at any time without prejudice

Exclusion Criteria:

Female subjects not pregnant or lactating
Subjects with known allergic reaction against one of the ingredients
Subjects with enlarged ovaries or cysts unrelated to polycystic ovarian disease.
Subjects with gynaecological bleeding of unknown origin
Subjects with ovarian, uterine, or mammary cancer
Subjects with hyperprolactinaemia
Subjects with tumors of the hypothalamus or the pituitary gland