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NCT Number: NCT04149496

IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer

A protocol was developed to improve pregnancy results after IVM compared to results from studies in the literature. Differences from most published protocols include the use of the Steiner-Tan needle to optimize oocyte environment during oocyte retrieval, use of oral medications and very low doses of FSH, and delayed embryo transfer during subsequent warmed cryo-preserved embryo transfer. Eligible patient have a PCO pattern in their ovaries during transvaginal ultrasound.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

All participants are candidates for IVF having PCOS or having PCO patterns in their ovaries who wish to undertake IVM for the potential advantages that it holds. All cycles are proceeded by oral contraceptive use for cycle scheduling purposes. Priming is done with oral letrozole with the addition of 25-75 IU daily starting after 2 days of letrozole. HCG is given when several follicle have diameters 8 mm or greater and no follicles have diameters greater than 13 mm. Oocyte retrieval is done approximately 38 hours later. A Steiner-Tan needle is used for oocyte retrieval in a manner that minimizes the amount of time that an oocyte is out of the ovary and not in a controlled laboratory environment. Oocytes are assessed for maturity for up to 48 hours post retrieval. If mature, oocytes are injected with sperm using ICSI. Embryos are grown to blastocysts and all blastocyst are vitrified. Warmed cryo-preserved blastocyst are transferred using routine IVF protocols during a subsequent cycle.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PCO pattern with > 25 antral follicles
  • AMH > 3.5

Exclusion criteria

  • BMI > 35
  • body morphology making transvaginal retrieval difficult or impossible
  • complicating medical condition making pregnancy or IVF relatively contra-indicated

Treatment and study plan

in vitro maturation of oocytes

Combination Product

Immature oocytes (rather than mature oocytes) are harvested as in IVF. These oocytes are allowed to mature in the laboratory before fertilization

Primary outcomes

  1. Percentage of treated patients having a clinical pregnancy

    Time frame: 12 weeks post transfer

    ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy

  2. Percentage of treated patients having an ongoing pregnancy

    Time frame: 10 months post transfer

    pregnancy with cardiac activity (by history or observations) after 12 weeks

Secondary outcomes

  1. Percentage of retrieved oocytes which matured per patient

    Time frame: 2 days post retrieval

    proportion of retrieved oocytes which are mature (polar body present) within 48 hours of retrieval

  2. Percentage of retrieved oocytes which fertilized per patient

    Time frame: 4 days post retrieval

    proportion of mature oocytes which display pronuclei

  3. Percentage of fertilized oocytes which divided

    Time frame: 6 days post retrieval

    proportion of fertilized oocytes which become 2 or more cells

  4. Percentage of fertilized oocytes which became blastocysts per patient

    Time frame: 8 days post retrieval

    proportion of fertilized oocytes which form a fluid filled cavity

  5. Percentage of patients who have a biochemical pregnancy after therir first transfer

    Time frame: 28 days post transfer

    proportion of patients with an hCG level greater than 5 measured post first transfer

Other outcomes

  1. Number of clinical pregnancies from subsequent transfers

    Time frame: up to one year after transfer of last patient enrolled

    Number of clinical pregnancies from all blastocyst transfers related to the retrieval

  2. Number of ongoing pregnancies from subsequent transfers

    Time frame: up to one year after transfer of last patient enrolled

    Number of ongoing pregnancies from blastocyst transfers related to the retrieval

Study contacts

Contact information is provided by the study sponsor or research team.

Bruce I Rose, MD, PhD

CONTACT

[email protected]

904-260-0352

Samuel Brown, MD

CONTACT

[email protected]

904-260-0352

Sponsors and collaborators

Lead sponsor

Bruce Rose, MD

Other

Registry information

Official study title

A Prospective Series of IVF Cases Utilizing in Vitro Maturation (IVM) With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Embryo Transfer Using a Subsequent Frozen Embryo Transfer Cycle

Acronym: IVMprt

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2019
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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