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Administration of FSH and Low Dose hCG for Oocyte Maturity While Decreasing hCG Exposure in IVF Cycles

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ClinicalTrials.gov Identifier: NCT02310919
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This is a randomized, double-blind, single center clinical trial study to compare the oocyte maturity, embryo development, and risk of ovarian hyperstimulation syndrome (OHSS) after receiving the standard dose of human chorionic gonadotropin (hCG) ovulation trigger or a lower dose of hCG plus concomitant follicle stimulating hormone (FSH) co-trigger in women undergoing in vitro fertilization (IVF).

Condition or disease Intervention/treatment Phase
Infertility Drug: Low dose hCG plus FSH co-trigger Drug: Standard dose of hCG Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Concomitant Administration of FSH With a Low Dose of hCG (1,500 IU) Has Equivalent Oocyte Developmental Competence While Decreasing the Exposure to hCG in IVF Cycles: A Double Blind Randomized Control Trial
Actual Study Start Date : September 2014
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : June 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Low dose hCG plus FSH co-trigger
On the day of ovulation trigger the patient will receive hCG 1,500 IU SQ plus FSH 450 IU SQ
Drug: Low dose hCG plus FSH co-trigger
Low dose hCG (1,500 IU) plus FSH (450 IU) co-trigger

Active Comparator: Standard dose of hCG alone
On the day of ovulation trigger the patient will receive standard dose of hCG (10,000 or 5,000 IU SQ)
Drug: Standard dose of hCG
Standard dose of hCG (10,000 or 5,000 IU) trigger




Primary Outcome Measures :
  1. Oocyte nuclear maturation [ Time Frame: 2 days ]
    The number of metaphase 2 oocytes, metaphase 1 oocytes, and germinal vesicles

  2. Fertilization [ Time Frame: 2 days ]
    The number of 2-pronuclei stage embryos after standard in vitro fertilization or intra-cytoplasmic sperm injection

  3. Oocyte recovery [ Time Frame: 2 days ]
    The number of oocytes retrieved from a mature sized follicle

  4. Embryo quality [ Time Frame: 6 days ]
    The embryo quality assessed by standard cleavage stage embryo grading system on day 3 of embryo culture. For any embryos grown to day 5, the embryo quality assessed by standard blastocyst grading system on day 5 of embryo culture.

  5. Pregnancy rates [ Time Frame: 14 days ]
    Clinical pregnancy rate defined as the presence of a fetal heart beat by ultrasound


Secondary Outcome Measures :
  1. Bloating Score [ Time Frame: 18 days ]
    Change in bloating scores from day of baseline ultrasound to post-trigger day 5

  2. Abdominal circumference [ Time Frame: 18 days ]
    Change in abdominal circumference from day of baseline ultrasound to post-trigger day 5

  3. Body Weight [ Time Frame: 18 days ]
    Change in body weight from day of baseline ultrasound to post-trigger day 5

  4. Physician visits post trigger [ Time Frame: 14 days ]
    The number of physician visits post trigger for symptoms of OHSS including hospitalization

  5. Severity of OHSS [ Time Frame: 14 days ]
    Categorization of OHSS based on grading system by Golan, et al. 1989. (Golan A, Ron-el R, Herman A, Soffer Y, Weinraub Z, Caspi E. Ovarian hyperstimulation syndrome: an update review. Obstetrical & Gynecological Survey 1989; 44:430-40)



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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: The target population includes couples undergoing IVF. All eligible couples will be asked to join the study. Study participants will be recruited from the Reproductive Endocrinology Clinic at University of California at San Francisco Center for Reproductive Health. Patients receiving any type of stimulation protocol for IVF will be offered participation in the study.

Exclusion Criteria:

  • Age >41 years old
  • Antral Follicle Count (AFC; 2-10 mm) < 8
  • Body Mass Index > 30 kg/m2
  • History of ≥ 2 prior canceled IVF cycles secondary to poor response
  • Diagnosis of cancer
  • Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study results
  • Undergoing embryo co-culture
  • Use of any of the following medications: Growth Hormone, Sildefanil, or Aspirin (except if being used for hypercoagulable state)
  • Severe male factor infertility diagnosis. Male factor infertility diagnosis should be cleared for eligibility by the PI based on previous patient history of fertilization outcomes and/or expected fertilization outcomes of the cause of male factor infertility based on known scientific data.
  • Ovulation trigger less than or greater than 36 hours to oocyte retrieval
  • Serum estradiol level >5,000 pg/ml on the day of expected trigger due to high risk of OHSS

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 ClinicalTrials.gov identifier (NCT number): NCT02310919


Locations
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United States, California
University of California at San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Ferring Pharmaceuticals
Investigators
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Principal Investigator: Mitchell Rosen, M.D. University of California, San Francisco
Publications:
Egbase PE, Sharhan MA, Masangcay M, Egbase E. Follicle stimulating hormone (FSH) administer with trigger dose human chorionic gonadotropin (hCG) completely prevents ovarian hyperstimulation (OHSS): Randomised controlled study. [Abstract] Fertil Steril 2011; 96(3): S20.

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02310919    
Other Study ID Numbers: P0503461
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Keywords provided by University of California, San Francisco:
Infertility
In vitro fertilization
IVF
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female