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

Not Applicable

Recruiting

• Conditions: Polycystic Ovary Syndrome
• Interventions: Combination Product: in vitro maturation of oocytes

• Registration Number: NCT04149496
• Lead Sponsor: Bruce Rose, MD

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-05-10
• Study First Submitted: 2019-07-09
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-31
• Last Update Submitted: 2019-10-31
• Study First Posted: 2019-11-04
• Last Update Posted: 2019-11-04
• Primary Completion: 2023-04-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All	in vitro maturation of oocytes	Patients requiring IVF treatment with PCOS or a PCO pattern in their ovaries who wish to undertake IVM (as a variant of their IVF procedure)

Primary Outcome Measures

Name	Time	Method
Percentage of treated patients having an ongoing pregnancy	10 months post transfer	pregnancy with cardiac activity (by history or observations) after 12 weeks
Percentage of treated patients having a clinical pregnancy	12 weeks post transfer	ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who have a biochemical pregnancy after therir first transfer	28 days post transfer	proportion of patients with an hCG level greater than 5 measured post first transfer
Percentage of retrieved oocytes which matured per patient	2 days post retrieval	proportion of retrieved oocytes which are mature (polar body present) within 48 hours of retrieval
Percentage of fertilized oocytes which divided	6 days post retrieval	proportion of fertilized oocytes which become 2 or more cells
Percentage of fertilized oocytes which became blastocysts per patient	8 days post retrieval	proportion of fertilized oocytes which form a fluid filled cavity
Percentage of retrieved oocytes which fertilized per patient	4 days post retrieval	proportion of mature oocytes which display pronuclei

Trial Locations

Locations (1)

Brown Fertility; 🇺🇸 Jacksonville, Florida, United States