Back to results

MENOPUR® Versus FOLLISTIM®

Primary Purpose

Infertility

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Menotropin

Progestrone vaginal insert

follitropin beta

Progesterone in oil

Ganirelix

About this trial

This is an interventional treatment trial for Infertility focused on measuring Healthy, pre-menopausal women, age 18-42 with a history of infertility and requiring IVF

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Pre-menopausal females between the ages of 18 and 42 years
Body mass index (BMI) of 18-34
Early follicular phase (day 2-4) Follicle stimulating hormone (FSH) <15 IU/L and Estradiol (E2) within normal limits
Documented history of infertility (e.g., unable to conceive for at least one year, or for 6 months for women >38 years of age, or bilateral tubal occlusion or absence, or male factor but excluding severe male factor requiring invasive or surgical sperm retrieval. Donor sperm may be used.)
Transvaginal ultrasound at screening consistent with findings adequate for assisted reproductive technology (ART) with respect to uterus and adnexa
Signed informed consent

Exclusion Criteria:

Gestational or surrogate carrier, donor oocyte
Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus, uterine cancer)
Surgical or medical condition which, in the judgment of the Investigator or Sponsor, may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used
Previous In vitro fertilization (IVF) or Assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response is defined as development of 2 mature follicles or history of >2 previous failed in vitro fertilization (IVF) cycles.
History of recurrent pregnancy loss (>2).
Presence of abnormal uterine bleeding of undetermined origin
Current or recent substance abuse, including alcohol or smoking >10 cigarettes per day
Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests
Participation in any experimental drug study within 30 days prior to Screening
Severe male factor requiring invasive or surgical sperm retrieval (e.g., microsurgical epididymal sperm aspiration [MESA], testicular sperm extraction [TESE])

Sites / Locations

Huntington Reproductive Center
San Diego Fertility Center
Conceptions Reproductive Associates of Colorado
Women's Medical Research Group, LLC
The Advanced IVF Institute; Charles E. Miller, MD & Associates
A Woman's Center for Reproductive Medicine
Center for Assisted Reproduction

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Menopur/Endometrin

Menopur/Progesterone in Oil

Follistim/Endometrin

Follistim/Progesterone in Oil

Arm Description

Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Outcomes

Primary Outcome Measures

Percentage of Participants With Ongoing Pregnancy at Week 8

The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound.

Secondary Outcome Measures

Number of Follicles Observed at Day 15

The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.

Number of Oocytes Retrieved at Day 18

The mean number of oocytes retrieved within 34-36 hours of human chorionic gonadotropin (hCG) administration.

Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved

The proportion of the number of oocytes inseminated (fertilized) of the total number of oocytes retrieved.

Number of Embryos Transferred at Three Stages of Development

The number of embryos, morula and blastocytes transferred to the study participant on either day 3 or day 5 following fertilization.

Number of Embryos Frozen at Day 24

The number of embryos that were not transferred but instead were frozen for future use.

Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle

A count of participants whose discontinuation was clearly documented on the study completion/termination form as 1) due to cycle cancelled or 2) cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).

Participants With Biochemical Pregnancy at Day 38

Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.

Participants With Clinical Pregnancy at Week 7

Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.

Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)

Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale: mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable. Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly.

Number of Live Births

Full Information

NCT ID

NCT00802360

First Posted

December 3, 2008

Last Updated

October 31, 2011

Sponsor

Ferring Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00802360

Brief Title

MENOPUR® Versus FOLLISTIM®

Official Title

A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in GnRH Antagonist Cycles

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles

Detailed Description

This multicenter, randomized, open-label exploratory study will be performed in approximately 200 healthy females undergoing in vitro fertilization (IVF). Each study center will follow its study center standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned prior to the start of stimulation to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified time periods during the cycle for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) tests, and first serum pregnancy test. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

Healthy, pre-menopausal women, age 18-42 with a history of infertility and requiring IVF

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

173 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Menopur/Endometrin

Arm Type

Experimental

Arm Description

Arm Title

Menopur/Progesterone in Oil

Arm Type

Experimental

Arm Description

Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Arm Title

Follistim/Endometrin

Arm Type

Active Comparator

Arm Description

Arm Title

Follistim/Progesterone in Oil

Arm Type

Active Comparator

Arm Description

Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Intervention Type

Drug

Intervention Name(s)

Menotropin

Other Intervention Name(s)

highly purified menotropins, Menopur®, hMG

Intervention Description

225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.

Intervention Type

Drug

Intervention Name(s)

Progestrone vaginal insert

Other Intervention Name(s)

progesterone, Endometrin®

Intervention Description

100 mg progesterone vaginal insert 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test.

Intervention Type

Drug

Intervention Name(s)

follitropin beta

Other Intervention Name(s)

Follistim Pen®, Follistim®

Intervention Description

225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.

Intervention Type

Drug

Intervention Name(s)

Progesterone in oil

Intervention Description

50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test.

Intervention Type

Drug

Intervention Name(s)

Ganirelix

Other Intervention Name(s)

ganirelix acetate, GnRH antagonist

Intervention Description

Ganirelix acetate 250 µg as a daily subcutaneous injection starting on day 6 and continuing until hCG criteria were met.

Primary Outcome Measure Information:

Title

Percentage of Participants With Ongoing Pregnancy at Week 8

Description

The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound.

Time Frame

Week 8 (Week 6 of gestation)

Secondary Outcome Measure Information:

Title

Number of Follicles Observed at Day 15

Description

The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.

Time Frame

Day 15

Title

Number of Oocytes Retrieved at Day 18

Description

The mean number of oocytes retrieved within 34-36 hours of human chorionic gonadotropin (hCG) administration.

Time Frame

Approximately Day 18

Title

Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved

Description

The proportion of the number of oocytes inseminated (fertilized) of the total number of oocytes retrieved.

Time Frame

Approximately Day 19

Title

Number of Embryos Transferred at Three Stages of Development

Description

The number of embryos, morula and blastocytes transferred to the study participant on either day 3 or day 5 following fertilization.

Time Frame

Approximately Day 24

Title

Number of Embryos Frozen at Day 24

Description

The number of embryos that were not transferred but instead were frozen for future use.

Time Frame

Approximately Day 24

Title

Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle

Description

Time Frame

Day 1 to Day 24

Title

Participants With Biochemical Pregnancy at Day 38

Description

Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.

Time Frame

approximately day 38 (Day 14 post embryo transfer)

Title

Participants With Clinical Pregnancy at Week 7

Description

Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.

Time Frame

approximately week 7

Title

Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)

Description

Time Frame

Day 1 - week 12

Title

Number of Live Births

Time Frame

Approximately 10 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

42 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pre-menopausal females between the ages of 18 and 42 years Body mass index (BMI) of 18-34 Early follicular phase (day 2-4) Follicle stimulating hormone (FSH) <15 IU/L and Estradiol (E2) within normal limits Documented history of infertility (e.g., unable to conceive for at least one year, or for 6 months for women >38 years of age, or bilateral tubal occlusion or absence, or male factor but excluding severe male factor requiring invasive or surgical sperm retrieval. Donor sperm may be used.) Transvaginal ultrasound at screening consistent with findings adequate for assisted reproductive technology (ART) with respect to uterus and adnexa Signed informed consent Exclusion Criteria: Gestational or surrogate carrier, donor oocyte Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus, uterine cancer) Surgical or medical condition which, in the judgment of the Investigator or Sponsor, may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used Previous In vitro fertilization (IVF) or Assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response is defined as development of 2 mature follicles or history of >2 previous failed in vitro fertilization (IVF) cycles. History of recurrent pregnancy loss (>2). Presence of abnormal uterine bleeding of undetermined origin Current or recent substance abuse, including alcohol or smoking >10 cigarettes per day Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests Participation in any experimental drug study within 30 days prior to Screening Severe male factor requiring invasive or surgical sperm retrieval (e.g., microsurgical epididymal sperm aspiration [MESA], testicular sperm extraction [TESE])

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Development Support

Organizational Affiliation

Ferring Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Huntington Reproductive Center

City

Pasadena

State/Province

California

ZIP/Postal Code

91105

Country

United States

Facility Name

San Diego Fertility Center

City

San Diego

State/Province

California

ZIP/Postal Code

92130

Country

United States

Facility Name

Conceptions Reproductive Associates of Colorado

City

Littleton

State/Province

Colorado

ZIP/Postal Code

80129

Country

United States

Facility Name

Women's Medical Research Group, LLC

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33759

Country

United States

Facility Name

The Advanced IVF Institute; Charles E. Miller, MD & Associates

City

Naperville

State/Province

Illinois

ZIP/Postal Code

60540

Country

United States

Facility Name

A Woman's Center for Reproductive Medicine

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70815

Country

United States

Facility Name

Center for Assisted Reproduction

City

Bedford

State/Province

Texas

ZIP/Postal Code

76022

Country

United States

12. IPD Sharing Statement

Learn more about this trial

MENOPUR® Versus FOLLISTIM®

We'll reach out to this number within 24 hrs