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Androgenic Profile Following Controlled Ovarian Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02992808
Recruitment Status : Not yet recruiting
First Posted : December 14, 2016
Last Update Posted : December 20, 2016
Information provided by (Responsible Party):
Dr. Eran Zilberberg, Sheba Medical Center

Brief Summary:
In this study the investigators will try to discover whether there is a difference for any of the stimulation preparations - recombinant FSH + recombinant LH (pergoveris & luveris) vs. human menopausal gonadotropin (menopur) during GnRH-antagonist cycles in the meaning of androgenic hormones profile. The study question is whether using recombinant LH will result in different follicular hormonal milieu, serum endocrine profile or IVF outcomes than using highly purified urinary gonadotropins with hCG mimicking LH activity.

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: recombinant gonadotropins Drug: HP-HMG Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Follicular Fluid, Serum Endocrine Profile Following Stimulation With Recombinant Gonadotropins or Highly Purified Human Menopausal Gonadotropin During GnRH-antagonist Protocol
Study Start Date : December 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Recombinant preparations Drug: recombinant gonadotropins
Other Name: Pergoveris & Luveris

Active Comparator: HP-HMG
Highly purified human menopausal gonadotropin
Drug: HP-HMG
Other Name: Menopur

Primary Outcome Measures :
  1. Serum hormonal profile [ Time Frame: (1) day 1-3 of menstruation (Day-S); (2) day of or prior to hCG administration (Day-hCG); and (3) day of ovum pick-up (Day-OPU). ]
    Hormonal profile = FSH, LH, progesterone, estradiol, testosterone, androstendione, 17-OH progesterone

  2. Follicular fluid hormonal profile [ Time Frame: Ovum pick up day ]
    Hormonal profile = FSH, LH, progesterone, estradiol, testosterone, androstendione, 17-OH progesterone

Secondary Outcome Measures :
  1. Implantation rate [ Time Frame: About three weeks after embryo transfer ]
    Number of gestational sacs on US exam / number of retrieved embryos

  2. Clinical pregnancy [ Time Frame: About three weeks after embryo transfer ]
    Number of cases with gestational sac per US exam / cases of embryo transfer

  3. Biochemical pregnancy [ Time Frame: About two weeks after embryo tranfer ]
    Positive BHCG test

  4. Ongoing pregnancy [ Time Frame: 10-12 weeks after embryo tranfer ]
    Number of viable pregnancies at about 10-12 weeks of gestation

  5. Live birth rate [ Time Frame: Until about 40 weeks after embryo transfer ]
    Number of pregnancies ended in a live birth

  6. Number of follicles [ Time Frame: During stimulation - one-two dayes before ovum pick-up ]
    Larger than 14 mm follicles per US

  7. Number of oocytes retrieved [ Time Frame: 1 day right after ovarian pick-up ]
    Number of oocytes retrieved during ovarian pick-up

  8. Number of embryos [ Time Frame: About 3 days after OPU (ovum pick-up) ]
    Number of developing embryos in the laboratory

  9. Number of top quality embryos [ Time Frame: 3 days after OPU ]
    The number of day 3 embryos with 7-8 cells with less than 15% fragmentation

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Infertile women between 20-40 years of age
  • BMI 19-35
  • undergoing their 1-4 IVF cycle

Exclusion Criteria:

  • Suspected PCOS
  • History of OHSS
  • Patients who had a chronic illness or were receiving chronic medical treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02992808

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Contact: Eran Zilberberg, MD +97235302882

Sponsors and Collaborators
Sheba Medical Center


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Responsible Party: Dr. Eran Zilberberg, Senior physician, Infertility & IVF Unit, Department of Obstetrics & Gynecology, Sheba Medical Center Identifier: NCT02992808     History of Changes
Other Study ID Numbers: SHEBA-16-3516-EZ-CTIL
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Eran Zilberberg, Sheba Medical Center:
Ovarian stimulation
Androgenic profile
Follicular fluid
Recombinant gonadotropins
human menopausal gonadotropin

Additional relevant MeSH terms:
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Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs