NCT07633002

Brief Summary

This study aims to explore whether the application of low-dose HCG in luteal support can improve the pregnancy outcomes of natural cycle frozen embryo transfer in obese patients

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Jul 2026

Status
not yet 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 Progress6%
Jul 2026Dec 2027

First Submitted

Initial submission to the registry

June 3, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1.5 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

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

June 3, 2026

Last Update Submit

June 3, 2026

Conditions

Obesity, Maternal

Keywords

obesity,IVF-ET,Frozen embryo transfer

Outcome Measures

Primary Outcomes (1)

  • Live birth

    Infants with vital signs who were born after 28 weeks of gestation.

    Pregnancy at 28 weeks or more

Secondary Outcomes (1)

  • Pregnancy outcome

    Check HCG 14 days after embryo transfer

Study Arms (2)

HCG in the luteal support of frozen embryo transfer during ovulation cycles in overweight women

EXPERIMENTAL

adding HCG on top of the conventional progesterone luteal support can improve the pregnancy outcomes of obese or overweight patients.

Drug: Human Chorionic Gonadotropin

Overweight women who received regular progesterone supplementation during the ovulation cycle

PLACEBO COMPARATOR

As the control group, the pregnancy outcomes of overweight and obese women who received regular progesterone supplementation during the ovulation cycle were observed.

Drug: Human Chorionic Gonadotropin

Interventions

Human Chorionic GonadotropinDRUG

The application of HCG（Human Chorionic Gonadotropin） in Luteal Support for frozen embryo transfer in Ovulation Cycle of Obese women: A single-center, open-label, randomized controlled trial study

Also known as: HCG
HCG in the luteal support of frozen embryo transfer during ovulation cycles in overweight womenOverweight women who received regular progesterone supplementation during the ovulation cycle

Eligibility Criteria

Age22 Years - 37 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≤37 years old ② Prepare the endometrium in the natural cycle/ovulation induction cycle ③ BMI≥24 according to the overweight standard for the Asian population ④ Single blastocyst transfer (including IVF and ICSI-assisted pregnancy) ⑤ At least one frozen blastocyst remaining in the IVF/ICSI cycle with a Gardner morphology score of ≥4BC, and the age of the frozen embryo is D5 or D6

You may not qualify if:

  • There is a history of adenomyosis, hydrosalpinx, intrauterine adhesions or untreated submucosal fibroids of the uterus
  • Uterine malformations; ③ The endometrial thickness on the conversion day is less than 7mm, or the cycle was cancelled during the endometrial preparation process before frozen embryo transfer due to the endometrium being less than 7mm in the past.
  • Have a history of the immune system, such as antiphospholipid syndrome/systemic lupus erythematosus/rheumatism; ⑤ Diabetic patients who have not been controlled by standardized medication; ⑥ Those who have undergone embryo transfer more than or equal to two times without achieving a live birth ⑦ Those whose embryos to be thawed and thawed are from donated or frozen egg sources, or have undergone two freezing operations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pregnancy in Obesity

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
archiater

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 8, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share