NCT07004192

Brief Summary

This prospective randomized trial will assess the relevance, if any, of a corpus luteum induced by hCG in transfers of thawed embryos.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
20mo left

Started Jun 2025

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Jun 2025Dec 2027

First Submitted

Initial submission to the registry

May 27, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

June 2, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

2.6 years

First QC Date

May 27, 2025

Last Update Submit

June 26, 2025

Conditions

Keywords

Thawed embryo transfer

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Mean arterial pressure measured in third trimester of pregnancy

    Third trimester of pregnancy

Study Arms (2)

hCG Group

EXPERIMENTAL

This group receives one injection of hCG.

Drug: HCG injection

No hCG Group

ACTIVE COMPARATOR

This arm receives no hCG.

Other: No intervention

Interventions

5000 IU hCG injection

hCG Group

No hCG administered in this group.

No hCG Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female adult expecting to receive transfer of a thawed embryo.
  • At least one available frozen blastocyst of transferrable quality.
  • Non-menopausal female with at least one antral follicle.
  • Use of pre-implantation genetic testing (PGT), embryos derived from donor oocytes and/or donor sperm, a gestational carrier, and history of prior transfer(s) regardless of outcome are allowed.
  • Subsequent embryo transfers after failed transfers under this study are allowed, but not after a transfer that has resulted in ongoing pregnancy at ten weeks gestation under this study.

You may not qualify if:

  • Minors (age\<18 years).
  • Use of embryo(s) frozen at another center.
  • Patient insistent on transfer of two embryos.
  • Patient or partner unable to provide informed consent in English.
  • Patient already enrolled in any other research study for her embryo transfer.
  • History of anti-phospholipid syndrome or any other indication for use of Lovenox in pregnancy.
  • Patient for whom the physician assesses this protocol is inappropriate or unsafe.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Center of Las Vegas

Las Vegas, Nevada, 89113, United States

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

Shironda Research Assistant

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 4, 2025

Study Start

June 2, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

No current plan to do so in approved protocol.

Locations