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Not yet recruitingNCT07633002Updated Jun 8, 2026

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

An interventional study of Human Chorionic Gonadotropin in Obesity, Maternal, sponsored by The Second Hospital of Shandong University. Not yet recruiting. Open to female participants aged 22 Years to 37 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by The Second Hospital of Shandong University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
22 Years to 37 Years
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Obesity, Maternal

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Keywords

  • obesity,IVF-ET,Frozen embryo transfer
03

In context

Pregnancy in Obesity

60 studies on the registry are indexed under Pregnancy in Obesity; 17 are open to participants now.

This study's planned enrollment of 750 is above the median of 160 across 33 interventional studies indexed under Pregnancy in Obesity.

Browse Pregnancy in Obesity studies →

Lead sponsor

The Second Hospital of Shandong University is the lead sponsor of 35 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 37 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≤37 years old ② Prepare the endometrium in the natural cycle/ovulation induction cycle ③ ≥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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
750 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • 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

06

What researchers measure

Primary outcomes

  1. Live birth

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

    Time frame: Pregnancy at 28 weeks or more

Secondary outcomes

  1. Pregnancy outcome

    Pregnancy outcomes: biochemical pregnancy, clinical pregnancy, ongoing pregnancy, termination of pregnancy, ectopic pregnancy, miscarriage

    Time frame: Check HCG 14 days after embryo transfer

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07633002
Lead sponsor
The Second Hospital of Shandong University
Responsible party
Linlin Cui (archiater, The Second Hospital of Shandong University) — Principal investigator
First posted
Jun 8, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jun 8, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Chorionic Gonadotropin

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