Impact of Endometrial Compaction in Euploid Frozen Embryo Transfers

NCT04330066 | Unknown

• 1 other identifier: 2020P000191
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to evaluate whether a decrease in endometrial thickness (compaction) prior to progesterone exposure (endogenous or exogenous) to the day before a single frozen embryo transfer has an impact on the clinical pregnancy rate with euploid embryos in exogenous hormone and modified natural thaw cycles. Information derived from this study may give insight on ways to improve pregnancy rates in cryo-thaw cycles.

Conditions

Infertility, Female

Keywords

endometrial compaction; frozen embryo transfer; euploid embryo; ultrasound

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  defined as confirmation of gestational sac with fetal heart beat on ultrasound between 6 - 9 weeks gestation

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Biochemical pregnancy rate

  through study completion, an average of 1 year

• Live birth rate

  through study completion, an average of 1 year

• Miscarriage rate

  through study completion, an average of 1 year

Study Arms (2)

Exogenous hormone replacement thaw cycle

Participants in this group will follow Boston IVF's standard exogenous hormone replacement protocol. Participants will take Estrace 3mg twice daily by mouth for endometrial preparation. After 16-18 days of Estrace, endometrial thickness will be measured by transvaginal ultrasound but medication and ultrasounds will be continued until the endometrial lining is ≥ 7 mm. Once the final endometrial lining is ≥ 7 mm (T1), the doctor of record will start the participant the following day with intramuscular progesterone daily or intramuscular progesterone every 3 days with daily vaginal progesterone. Frozen embryo transfers would occur on the sixth day of progesterone.

Diagnostic Test: Abdominal ultrasound measurement of the endometrial lining

Natural thaw cycle

Participants in this group will follow Boston IVF's standard natural thaw cycle protocol. Participants will be coming for blood and transvaginal ultrasound monitoring around day 11 of the participants cycle. Once the participant has a final measurement of the endometrial lining ≥ 7 mm (T1), a 17mm ovarian follicle, and a progesterone \< 1.2 ng/mL, the doctor of record will schedule the patient to receive a trigger injection to induce ovulation followed by an embryo transfer 6-7 days later. Participants may be started on vaginal progesterone 4 days after the trigger injection for added supplementation per the doctor of record.

Diagnostic Test: Abdominal ultrasound measurement of the endometrial lining

Interventions

Abdominal ultrasound measurement of the endometrial lining DIAGNOSTIC_TEST

On the day of the participants frozen embryo transfer, an endometrial thickness measurement (T2) will obtained from an abdominal ultrasound during the embryo transfer.

Exogenous hormone replacement thaw cycle; Natural thaw cycle

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants that are having a single frozen embryo transfer with a euploid embryo.

You may qualify if:

• Single euploid frozen embryo transfer
• ≥ 7 mm endometrial lining on transvaginal ultrasound
• st or 2nd frozen embryo transfer

You may not qualify if:

• Obesity with body mass index \> 40
• Underweight with body mass index \< 18.5
• Utilization of a gestational carrier
• History of recurrent pregnancy loss (≥ 2 spontaneous abortions)
• Uterine factors (history of uterine adhesions, uterine surgery, fibroids, polyps)
• History of an endometrial receptivity assay (ERA) biopsy

Sponsors & Collaborators

• Boston IVF: lead

Study Sites (1)

Boston IVF

Boston, Massachusetts, 02109, United States

Location

Related Publications (1)

• Shah JS, Vaughan DA, Dodge LE, Leung A, Korkidakis A, Sakkas D, Ryley DA, Penzias AS, Toth TL. Endometrial compaction does not predict live birth in single euploid frozen embryo transfers: a prospective study. Hum Reprod. 2022 May 3;37(5):980-987. doi: 10.1093/humrep/deac060.

  PMID: 35357436 DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Alan Penzias, MD

  Boston IVF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: September 1, 2020
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)