CONSORT Randomized Controlled Trial in Assisted Reproductive Technology

NCT ID: NCT00829244

Last Updated: 2014-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-01-31

Brief Summary

The overall objective of this trial is to compare the ovarian response in assisted reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment' (CONSORT) calculator versus given a standard GONAL f® dose of 150 International Unit (IU) per day.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CONSORT Dosing

GONAL-f® dose based on subject baseline characteristics determined according to the CONSORT calculator

Group Type: EXPERIMENTAL

GONAL f® prefilled pen

Intervention Type: DRUG

GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for 1 cycle only

Standard Dosing

GONAL-f® at a standard dose of 150 IU per day

Group Type: ACTIVE_COMPARATOR

GONAL f® prefilled pen

Intervention Type: DRUG

GONAL f® standard treatment arm (150 IU of GONAL f® per day) up to Day 5 of stimulation after which the dose can be adjusted based upon the subject's ovarian response and according to the center's standard practice.

Interventions

GONAL f® prefilled pen

GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for 1 cycle only

Intervention Type: DRUG

GONAL f® prefilled pen

GONAL f® standard treatment arm (150 IU of GONAL f® per day) up to Day 5 of stimulation after which the dose can be adjusted based upon the subject's ovarian response and according to the center's standard practice.

Intervention Type: DRUG

Other Intervention Names

Follitropin alfa; Recombinant human follicle stimulating hormone (r-hFSH); GONAL-f® Prefilled Pen; Follitropin alfa; r-hFSH; GONAL-f® Prefilled Pen

Eligibility Criteria

Inclusion Criteria

1. Female subjects justifying an in-vitro fertilization (IVF)/embryo transfer (ET) treatment

2. Have a male partner with semen analysis within the past 6 months prior to randomization considered adequate to proceed with regular insemination or intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used

3. Between her 18th and 35th birthday (35 not included) at the time of the randomization visit

4. Body mass index (BMI) lower than 30 kilogram per square meter (kg/m^2) where the BMI is calculated according to the formula

5. Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length

6. Have an early follicular phase (Day 2-4) serum level of basal FSH lower than or equal to 12 International Unit per Liter (IU/L) measured in the center's local laboratory during the screening period (i.e. within 2 months prior to down-regulation start)

7. Presence of both ovaries

8. Normal uterine cavity, which in the investigator's opinion is compatible with pregnancy

9. Have a negative cervical papanicolaou (PAP) test within the last 6 months prior to randomization

10. Have at least 1 wash-out cycle (defined as greater than or equal to 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotropin releasing hormone (GnRH) agonist therapy

11. Willing and able to comply with the protocol for the duration of the trial

12. Have given written informed consent, prior to any trial-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care

Exclusion Criteria

1. Have greater than or equal to 2 previous ART cycles with a poor response to gonadotrophin stimulation (defined as lower than or equal to 5 mature follicles and/or lower than or equal to 3 oocytes collected) or have greater than or equal to 2 previous ART cycles with a hyper response (defined as greater than or equal to 25 oocytes retrieved)

2. Any medical condition, which in the judgment 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 Merck Serono's Medical responsible

3. Have previous severe ovarian hyperstimulation syndrome (OHSS)

4. Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS

5. Presence of endometriosis requiring treatment

6. Uterine myoma requiring treatment

7. Any contraindication to being pregnant and/or carrying a pregnancy to term

8. Extra-uterine pregnancy within the last 3 months prior to screening

9. History of 3 or more miscarriages (early or late miscarriages) due to any cause

10. Tumors of the hypothalamus and pituitary gland

11. Ovarian enlargement or cyst of unknown etiology

12. Ovarian, uterine or mammary cancer

13. A clinically significant systemic disease

14. Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner,

15. Abnormal gynecological bleeding of undetermined origin

16. Known allergy or hypersensitivity to human gonadotrophin preparations,

17. Any active substance abuse or history of drug medication or alcohol abuse in the past 5 years prior to the screening visit

18. Entered previously into this trial or simultaneous participation in another clinical trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pablo Arriagada, MD

Role: STUDY_DIRECTOR

Merck Serono S.A., Geneva

Locations

Research Site

Geneva, , Switzerland

Countries

Switzerland

References

Olivennes F, Trew G, Borini A, Broekmans F, Arriagada P, Warne DW, Howles CM. Randomized, controlled, open-label, non-inferiority study of the CONSORT algorithm for individualized dosing of follitropin alfa. Reprod Biomed Online. 2015 Mar;30(3):248-57. doi: 10.1016/j.rbmo.2014.11.013. Epub 2014 Dec 15.

Reference Type: DERIVED

PMID: 25596910 (View on PubMed)

Other Identifiers

28613

Identifier Type: -

Identifier Source: org_study_id