The Application of HCG in Luteal Support for Frozen Embryo Transfer in Ovulation Cycle of Obese Women

The Application of HCG in the Luteal Support of Frozen Embryo Transfer During Ovulation Cycles in Overweight and Obese Women

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

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity, Maternal
• Intervention / Treatment: Drug: Human Chorionic Gonadotropin

Detailed Description

In ART, due to ovulation induction and the particularity of the population, luteal phase deficiency usually exists, and in clinical practice, luteal phase support is routinely strengthened. Progesterone is commonly used for luteal support in clinical practice. According to the Chinese expert consensus on luteal support, HCG can be used for luteal support in the absence of OHSS. HCG can increase progesterone secretion by endogenous stimulation of luteal function and exogenous addition of HCG to enhance luteal support, thereby increasing progesterone production and maintaining luteal function.

At present, it remains unclear whether HCG can improve pregnancy outcomes. Previous studies have indicated that compared with conventional luteal support, HCG has not significantly improved the pregnancy outcomes of frozen-thawed embryo transfer in ovulation cycles (NC). However, with the development and progress of FET technology, while reducing the impact of the technology on frozen embryos, we once again explored whether adding HCG on the basis of traditional luteal support in NC-FET could improve the pregnancy outcomes of obese or overweight patients, providing a theoretical basis for the clinical application of HCG.

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HCG in the luteal support of frozen embryo transfer during ovulation cycles in overweight women; adding HCG on top of the conventional progesterone luteal support can improve the pregnancy outcomes of obese or overweight patients.	Drug: Human Chorionic Gonadotropin; 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; Other Names: HCG
Placebo Comparator: Overweight women who received regular progesterone supplementation during the ovulation cycle; 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; 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; Other Names: HCG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live birth	Infants with vital signs who were born after 28 weeks of gestation.	Pregnancy at 28 weeks or more

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy outcome	Pregnancy outcomes: biochemical pregnancy, clinical pregnancy, ongoing pregnancy, termination of pregnancy, ectopic pregnancy, miscarriage	Check HCG 14 days after embryo transfer

Collaborators and Investigators

• Sponsor: The Second Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: obesity,IVF-ET,Frozen embryo transfer
• Additional Relevant MeSH Terms: Urogenital Diseases; Nutrition Disorders; Female Urogenital Diseases and Pregnancy Complications; Overnutrition; Body Weight; Pregnancy Complications; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pregnancy in Obesity; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Gonadotropins; Placental Hormones; Pregnancy Proteins; Chorionic Gonadotropin
• Other Study ID Numbers: KYLL202511788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No