The Role of hCG in Thawed Embryo Transfer

NCT ID: NCT07004192

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-02

Study Completion Date

2027-12-31

Brief Summary

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

Detailed Description

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The current study is designed to carefully isolate the effect of a corpus luteum by ensuring that the presence or absence of a corpus luteum is the only difference between two study arms. This should be reliably achieved by administering an injection of hCG in one study arm, while the other study arm has identical treatment except for omitting the hCG.

Conditions

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Infertility (IVF Patients)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hCG Group

This group receives one injection of hCG.

Group Type EXPERIMENTAL

HCG injection

Intervention Type DRUG

5000 IU hCG injection

No hCG Group

This arm receives no hCG.

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type OTHER

No hCG administered in this group.

Interventions

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HCG injection

5000 IU hCG injection

Intervention Type DRUG

No intervention

No hCG administered in this group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Female adult expecting to receive transfer of a thawed embryo.
2. At least one available frozen blastocyst of transferrable quality.
3. Non-menopausal female with at least one antral follicle.
4. 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.
5. 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.

Exclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fertility Center of Las Vegas

INDUSTRY

Sponsor Role lead

Responsible Party

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Bruce Shapiro M.D.

Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fertility Center of Las Vegas

Las Vegas, Nevada, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shironda Research Assistant

Role: CONTACT

702-254-1777 ext. 265

Facility Contacts

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Shironda Research Assistant

Role: primary

702-254-1777 ext. 265

Other Identifiers

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FCLV 2025-1

Identifier Type: -

Identifier Source: org_study_id

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