Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01312766
• Date of registration: 07/03/2011
• Prospective Registration: No
• Primary sponsor: IBSA Institut Biochimique SA
• Public title: Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients
• Scientific title: Safety and Efficacy Study Comparing a New hMG Formulation (hMG-IBSA) to a Reference Product (Menopur®) in Patients Undergoing Ovarian Stimulation for in Vitro Fertilisation (IVF)
• Date of first enrolment: February 2011
• Target sample size: 270
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01312766
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Denmark, France, Hungary, Switzerland, United Kingdom

Contacts

• Name: Dominique De Ziegler, MD, Prof
• Affiliation: Hopital Cochin

Key inclusion & exclusion criteria

Inclusion Criteria:

- Women undergoing ovarian stimulation for IVF with the following characteristics:

- Able and willing to sign the Patient Consent Form and adhere to the study
visitation schedule

- >18 and <40 years old

- BMI between 18 and 30 kg/m2

- less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery)

- basal FSH <10 IU/L and E2 <80 pg/ml (~290 pmol/l)

- Within 12 months of the beginning of the study, uterine cavity consistent with
expected normal function as assessed through transvaginal ultrasound,
hysterosalpingogram, sonohysterogram or hysteroscopic examination

- Successful down-regulation performed with a standard GnRH-Agonist long protocol
(Criteria for successful down-regulation: endometrial thickness < 7mm or serum E2
level <50 pg/ml (~185 pmol/l).

Exclusion Criteria:

- age <18 and >40 years

- primary ovarian failure or women known as poor responders (i.e. requiring more than
225 IU of hMG as a starting dose in previous treatment cycles or having less than 3
oocytes retrieved, or with a pre-ovulatory E2 serum concentration <500pg/ml (~1800
pmol/l))

- PCOS

- one or both ovaries inaccessible for oocyte retrieval

- ovarian cysts >10 mm

- hydrosalpinx that have not been surgically removed or ligated;

- stage 3 or 4 endometriosis

- oocyte donation

- implantation of previously frozen embryos

- patients affected by pathologies associated with any contraindication of being
pregnant

- hypersensitivity to the study medication

- abnormal bleeding of undetermined origin

- uncontrolled thyroid or adrenal dysfunction

- neoplasias

- severe impairment of renal and/or hepatic function

- use of concomitant medications that might interfere with study evaluations (e.g.
non-study hormonal medications, prostaglandin inhibitors, psychotropic agents)



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Infertility

Intervention(s)

Drug: Menotropins

Primary Outcome(s)

Total Number of Oocytes Retrieved [Time Frame: up to 24 days after treatment start]

Secondary Outcome(s)

Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo) [Time Frame: up to 28 days after treatment start]

Clinical Pregnancy Rate, [Time Frame: 10 - 11 weeks after embryo transfer]

Live Birth Rate [Time Frame: 9 months after treatment]

Controlled Ovarian Stimulation Duration (Days) [Time Frame: up to 23 days after treatment start]

Implantation Rate [Time Frame: 10-11 weeks after embryo transfer]

Total Number of Inseminated Oocytes (IVF and ICSI) [Time Frame: on the day of oocyte retrieval]

17-ß Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection; [Time Frame: up to 23 days after treatment start]

Number of Mature (Grade III Metaphase II) Oocytes Retrieved. [Time Frame: at the end of the stimulation.]

Mean hMG Dose (Total); [Time Frame: up to 22 days after treatment start]

Number of Cleaved Embryos [Time Frame: two days after insemination]

Ratio Mature/Total Number of Oocytes Retrieved. [Time Frame: at the end of the stimulation.]

Positive b-hCG Test [Time Frame: up to 5 weeks after treatment start]

Secondary ID(s)

10EU/hMG02

2010-021021-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/08/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01312766