Obesity, MaternalNCT07633002
The Application of HCG in Luteal Support for Frozen Embryo Transfer in Ovulation Cycle of Obese Women
A study testing Human Chorionic Gonadotropin in people with Obesity, Maternal, run by The Second Hospital of Shandong University.
Trial 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 more about this study
- Who is it for?
- Ages 22 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Maternal
- What is being tested?
- Human Chorionic Gonadotropin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
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.
- Conditions
- Obesity, Maternal
- Being tested
- Human Chorionic Gonadotropin
- Keywords
- obesity,IVF-ET,Frozen embryo transfer
- Medical subject headings
- Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Chorionic GonadotropinDrug
Also called HCG
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Human Chorionic Gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth
Infants with vital signs who were born after 28 weeks of gestation.
Measured: 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
Measured: Check HCG 14 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MaternalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linlin Cui, The Second Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633002
- Sponsor's protocol ID
- KYLL202511788
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of HCG in the Luteal Support of Frozen Embryo Transfer During Ovulation Cycles in Overweight and Obese Women
- ClinicalTrials.gov ID
- NCT07633002
- Acronym / sponsor ID
- KYLL202511788
- Conditions
- Obesity, Maternal
- Keywords
- obesity,IVF-ET,Frozen embryo transfer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCG in the luteal support of frozen embryo transfer during ovulation cycles in overweight women | Experimental | Drug: Human Chorionic Gonadotropinadding HCG on top of the conventional progesterone luteal support can improve the pregnancy outcomes of obese or overweight patients. |
| Overweight women who received regular progesterone supplementation during the ovulation cycle | Placebo comparator | Drug: Human Chorionic GonadotropinAs the control group, the pregnancy outcomes of overweight and obese women who received regular progesterone supplementation during the ovulation cycle were observed. |
Who may qualify
- Ages
- 22 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- There is a history of adenomyosis, hydrosalpinx, intrauterine adhesions or untreated submucosal fibroids of the uterus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Chorionic GonadotropinAlso: HCGThe 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 | Drug | HCG in the luteal support of frozen embryo transfer during ovulation cycles in overweight women, Overweight women who received regular progesterone supplementation during the ovulation cycle |
Primary outcome
Live birth
Time frame: Pregnancy at 28 weeks or more
Infants with vital signs who were born after 28 weeks of gestation.
1 secondary outcome
Pregnancy outcome
Time frame: Check HCG 14 days after embryo transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Human Chorionic Gonadotropin in people with Obesity, Maternal, run by The Second Hospital of Shandong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth (time frame: Pregnancy at 28 weeks or more). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.