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Maximal Stimulation and Delayed Fertilization for Diminished Ovarian Reserve: a Randomized Pilot Study

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ClinicalTrials.gov Identifier: NCT01921166
Recruitment Status : Completed
First Posted : August 13, 2013
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Brad Hurst, Atrium Health

Brief Summary:

The purpose of the study is (A) to determine if the following novel approach improves the live birth rate with In-Vitro Fertilization (IVF) for women with a poor prognosis due to diminished ovarian reserve:

  • ovarian stimulation with medications that are effective in women with diminished ovarian reserve but adversely affect the endometrium
  • oocyte retrieval and vitrification
  • fertilization and embryo transfer in a subsequent cycle with controlled endometrial preparation B) To determine the optimal stimulation protocol for women with diminished ovarian reserve incorporating oocyte vitrification

Women who are not eligible to participate in the Carolinas Medical Center (CMC) Assisted Reproductive Therapy program because of an extremely poor prognosis will be recruited for a prospective, randomized, open-label study to determine if a novel approach improves the live birth rate with traditional IVF "poor prognosis" stimulation protocols. The novel approach will incorporate one of two protocols utilizing medications that provide maximal ovarian stimulation but have a temporary detrimental fertility-reducing effect on the endometrium. If ovarian stimulation is adequate, oocyte retrieval will be performed and viable oocytes vitrified (stored in a "glass-like" state in liquid nitrogen). At a later time, oocyte warming and fertilization will be performed in a subsequent cycle, in which the endometrium has been prepared.

Key points include:

  • Randomization to one of two ovarian stimulation protocols that have been shown to have a detrimental effect on the endometrium, and therefore are rarely used in a "fresh" IVF cycle
  • Oocyte vitrification is considered to be an investigational procedure by the American Society of Reproductive Medicine (ASRM), and should only be performed under the supervision of an IRB. With oocyte vitrification, ovarian stimulation and oocyte retrieval can "unlinked" from embryo transfer, allowing embryo transfer to occur in a more optimal environment
  • Endometrial preparation is routine for frozen embryo transfer

Condition or disease Intervention/treatment Phase
Infertility Drug: clomiphene plus gonadotropins Drug: Leuprolide flare Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maximal Stimulation and Delayed Fertilization for Diminished Ovarian Reserve: a Randomized Pilot Study
Study Start Date : January 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: clomiphene plus gonadotropins
clomiphene plus gonadotropins
Drug: clomiphene plus gonadotropins
clomiphene plus gonadotropin ovulation induction
Other Name: Clomid. Serophene. Gonal f. Bravelle. Follistim. Menopur.

Active Comparator: Leuprolide flare
Leuprolide flare
Drug: Leuprolide flare
Leuprolide flare ovulation induction
Other Name: Lupron.




Primary Outcome Measures :
  1. Oocytes [ Time Frame: up to 24 months ]
    Number of oocytes retrieved


Secondary Outcome Measures :
  1. Number of Oocytes Vitrified [ Time Frame: up to 24 months ]

Other Outcome Measures:
  1. Number of Embryos From Vitrified Oocytes [ Time Frame: up to 24 months ]
    per ovarian stimulation treatment protocol



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Basal FSH 17 IU/mL (highest ever)
  • Basal FSH 15-17 (highest ever) and failed EFORT test
  • Age > 43 at the time of expected retrieval
  • Failure to conceive with a prior "poor prognosis" IVF stimulation protocol (microdose leuprolide flare or GnRH antagonist cycle) if administered because of evidence of diminished ovarian reserve
  • Failure to conceive with 3 or more IVF cycles at CMC

Exclusion Criteria:

  • Contraindications to IVF
  • Contraindication to pregnancy
  • Allergy or contraindication to medications used for IVF or embryo transfer
  • Use for a gestational carrier
  • Uncorrected or untreatable uterine infertility
  • Smoking or substance abuse within 3 months of initiating stimulation for IVF

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): NCT01921166


Sponsors and Collaborators
Atrium Health
Investigators
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Principal Investigator: Bradley S Hurst, M.D. Atrium Health

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Responsible Party: Brad Hurst, Director, Assisted Reproductive Therapies, Atrium Health
ClinicalTrials.gov Identifier: NCT01921166     History of Changes
Other Study ID Numbers: Diminished Ovarian Reserve
First Posted: August 13, 2013    Key Record Dates
Results First Posted: February 23, 2018
Last Update Posted: February 23, 2018
Last Verified: January 2018

Keywords provided by Brad Hurst, Atrium Health:
infertility
diminished ovarian reserve
fertilization in vitro
ovulation inducion
vitrification

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Clomiphene
Enclomiphene
Zuclomiphene
Leuprolide
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Antineoplastic Agents, Hormonal
Antineoplastic Agents