Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF)

Phase 4

Completed

Conditions: Infertility

Interventions: Drug: Gonal-f
Drug: Recombinant human chorionic gonadotrophin (r-hCG)

Registration Number: NCT00249834

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary: Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 166

Inclusion Criteria

Not provided

Exclusion Criteria

Had 2 previous ART cycles with a poor response to gonadotrophin stimulation, defined as less than or equal to (<=) 5 mature follicles and/or <=3 oocytes collected in any previous IVF cycle or hyper response, defined as >=25 oocytes retrieved.
Any medical condition, which in the judgement of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Serono's Therapeutic Director.
Had previous severe ovarian hyperstimulation syndrome (OHSS).
A body mass index (BMI) greater than (>) 30 kilogram per square meter (kg/m^2)
Any contraindication to being pregnant and/or carrying a pregnancy to term.
Extra-uterine pregnancy within the last 3 months.
History of 3 or more miscarriages (early or late miscarriages) due to any cause.
Tumours of the hypothalamus and pituitary gland.
Ovarian enlargement or cyst of unknown aetiology.
Ovarian, uterine or mammary cancer.
A clinically significant systemic disease.
Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus.
Abnormal gynaecological bleeding of undetermined origin.
Known allergy or hypersensitivity to human gonadotrophin preparations.
Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years.
Entered previously into this study or simultaneous participation in another clinical trial

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gonal-f 112.5 IU	Recombinant human chorionic gonadotrophin (r-hCG)	-
Gonal-f 37.5 IU	Gonal-f	-
Gonal-f 37.5 IU	Recombinant human chorionic gonadotrophin (r-hCG)	-
Gonal-f 75 IU	Gonal-f	-
Gonal-f 75 IU	Recombinant human chorionic gonadotrophin (r-hCG)	-
Gonal-f 150 IU	Recombinant human chorionic gonadotrophin (r-hCG)	-
Gonal-f 112.5 IU	Gonal-f	-
Gonal-f 187.5 IU	Gonal-f	-
Gonal-f 187.5 IU	Recombinant human chorionic gonadotrophin (r-hCG)	-
Gonal-f 225 IU	Recombinant human chorionic gonadotrophin (r-hCG)	-
Gonal-f 225 IU	Gonal-f	-
Gonal-f 262.5 IU	Recombinant human chorionic gonadotrophin (r-hCG)	-
Gonal-f 262.5 IU	Gonal-f	-
Gonal-f 300 IU	Recombinant human chorionic gonadotrophin (r-hCG)	-
Gonal-f 150 IU	Gonal-f	-
Gonal-f 300 IU	Gonal-f	-

Primary Outcome Measures

Name	Time	Method
Number of Oocytes Retrieved	Ovum pick up day (34 to 38 hours post r-hCG administration)	Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.

Secondary Outcome Measures

Name	Time	Method
Mean Number of Ovarian Stimulation Days	up to end of stimulation cycle (approximately 31 days)	The mean number of stimulation days were determined based on the treatment administration information collected in the case report form. Ovarian stimulation included time from first r-hFSH injection (stimulation Day) until day on which r-hCG was administered (r-hCG day). As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Percentage of Cycles Cancelled Due to Excessive or Inadequate Response to r-hFSH	up to end of stimulation cycle (approximately 31 days)	As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Number of Subjects Needing Dose Adjustment	6 days post r-hFSH treatment	Number of subjects needing increase in dose, decrease in dose or increase and decrease both in dose were reported. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Mean Daily Recombinant Human Follicle Stimulating Hormone (r-hFSH) Dose	up to end of stimulation cycle (approximately 31 days)	As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)	up to end of stimulation cycle (approximately 31 days)	As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Overall Pregnancy Rate, Clinical Rate and Multiple Pregnancy Rate	35-42 days post r-hCG administration	Overall pregnancy rate was defined as the percentage of subjects with serum beta-hCG levels greater than 10 IU/L. Clinical pregnancy rate was defined as the percentage of subjects with at least 1 ultrasound confirmed gestational sac, with or without foetal heart activity. Multiple pregnancy rate was defined as the percentage of subjects with more than 1 ultrasound confirmed gestational sac in the uterus with fetal heart activity. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Embryo Implantation Rate	35-42 days post r-hCG administration	Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.