Infertility, FemaleNCT03578172
HMG Stimulation Versus HRT for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe IUA Patients
A study testing human menopausal gonadotrophin and hormone replacement therapy in people with Infertility, Female and Intrauterine Adhesion, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
Trial summary
Evaluation of endometrial preparation using either human menopausal gonadotrophin (HMG) stimulation and hormone replacement therapy (HRT) prior to blastocyst transfer in patients with moderate to severe intrauterine adhesion (IUA). Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Infertility, Female, Intrauterine Adhesion
- What is being tested?
- human menopausal gonadotrophin and hormone replacement therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2018to 20 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BMI 18~23 kg/m2
- Women with moderate to severe IUA as defined by the American Fertility Society classification (1988)
- Presence of at least 3 cryopreserved cleavage-stage embryos (including 1 good quality) or blastocysts
Who cannot join
- Using embryos from donor oocytes
- Preimplantation genetic diagnosis(PGD)/Preimplantation genetic screening(PGS) cycles
- Moderate or severe endometriosis
- Untreated unilateral or bilateral hydrosalpinx
- Uterine adenomyosis, uterine myoma (submucous,intramural myoma >4 cm),>1cm septate uterus, double uterus, bicornuate uterus, unicornuate uterus
Trial locations and contacts
1 site in 1 country.
China1 site
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, 410000
About this study
Official title: Randomized, Controlled Trial to Assess the Efficacy of Human Menopausal Gonadotrophin Stimulation and Hormone Replacement Therapy for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe Intrauterine Adhesion Patients
Evaluation of endometrial preparation using either human menopausal gonadotrophin (HMG) stimulation and hormone replacement therapy (HRT) prior to blastocyst transfer in patients with moderate to severe intrauterine adhesion (IUA).
- Conditions
- Infertility, Female, Intrauterine Adhesion
- Being tested
- human menopausal gonadotrophin, hormone replacement therapy
- Medical subject headings
- Infertility, Female, Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human menopausal gonadotrophinDrug
experimental group:Women will be given HMG 37.5-150IU daily followed by monitoring of the follicular growth (folliculometry) when serum Estradiol (E2)<100pg/ml，progesterone (P)<1ng/ml. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle ≥20mm in diameter followed by luteal phase support (using progesterone supplements) after 24 hours.
hormone replacement therapyDrug
Women will be given 17 β-estradiol hemihydrate 2 mg and estrogen gel 5 g daily from day 3 of the cycle then the endometrial thickness will be assessed on day 7 by transvaginal sonography (TVS). If the endometrium is ≥ 9 mm, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 9 mm, estradiol will be continued until reaching appropriate endometrial thickness and then the luteal phase support will be started. The cycle will be cancelled If the estradiol administration >60 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental-HMG stimulation group | Experimental | Women will be subjected to ovarian stimulation for endometrial preparation using human menopausal gonadotrophin before blastocyst transfer Receives: Drug: human menopausal gonadotrophin |
| Control-HRT group | Active comparator | Women will be subjected to hormone replacement therapy for endometrial preparation before blastocyst transfer Receives: Drug: hormone replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Ongoing pregnancy is defined as the presence of a gestational sac with foetal heartbeat by transvaginal ultrasound at 10th week after embryo transfer（ET）
Measured: 10th week after embryo transfer
Secondary outcomes (5)
Cycle cancellation rate
Measured: the day of embryo transfer
Implantation rate
Sacs seen in early ultrasound divided by the number of embryos transferred
Measured: 4th weeks after embryo transfer
Clinical pregnancy rate
Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers
Measured: 4th weeks after embryo transfer
Early miscarriage rate
Number of losses of clinical pregnancies divided by number of clinical pregnancies
Measured: 12th weeks gestational age
Biochemical pregnancy rate
number of pregnancies with a transient elevation of serum human chorionic gonadotropin(β-hCG) level (>10 mIU/ml) divided by number of embryo transfers
Measured: 4th weeks 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 posted6 Jul 2018
- Study start18 Jul 2018
- Primary completion20 Oct 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578172
- Sponsor's protocol ID
- KYXM-2018001
- Status last verified
- Jan 2022
- First submitted
- 24 Jun 2018
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial to Assess the Efficacy of Human Menopausal Gonadotrophin Stimulation and Hormone Replacement Therapy for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe Intrauterine Adhesion Patients
- ClinicalTrials.gov ID
- NCT03578172
- Acronym / sponsor ID
- KYXM-2018001
- Conditions
- Infertility, Female, Intrauterine Adhesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 20 Oct 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 6 Jul 2018 (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.
Evaluation of endometrial preparation using either human menopausal gonadotrophin (HMG) stimulation and hormone replacement therapy (HRT) prior to blastocyst transfer in patients with moderate to severe intrauterine adhesion (IUA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental-HMG stimulation group | Experimental | Drug: human menopausal gonadotrophinWomen will be subjected to ovarian stimulation for endometrial preparation using human menopausal gonadotrophin before blastocyst transfer |
| Control-HRT group | Active comparator | Drug: hormone replacement therapyWomen will be subjected to hormone replacement therapy for endometrial preparation before blastocyst transfer |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 18~23 kg/m2
- Women with moderate to severe IUA as defined by the American Fertility Society classification (1988)
- Presence of at least 3 cryopreserved cleavage-stage embryos (including 1 good quality) or blastocysts
Key exclusion criteria (5 listed)
- Using embryos from donor oocytes
- Preimplantation genetic diagnosis(PGD)/Preimplantation genetic screening(PGS) cycles
- Moderate or severe endometriosis
- Untreated unilateral or bilateral hydrosalpinx
- Uterine adenomyosis, uterine myoma (submucous,intramural myoma >4 cm),>1cm septate uterus, double uterus, bicornuate uterus, unicornuate 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 menopausal gonadotrophinexperimental group:Women will be given HMG 37.5-150IU daily followed by monitoring of the follicular growth (folliculometry) when serum Estradiol (E2)<100pg/ml，progesterone (P)<1ng/ml. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle ≥20mm in diameter followed by luteal phase support (using progesterone supplements) after 24 hours. | Drug | Experimental-HMG stimulation group |
| hormone replacement therapyWomen will be given 17 β-estradiol hemihydrate 2 mg and estrogen gel 5 g daily from day 3 of the cycle then the endometrial thickness will be assessed on day 7 by transvaginal sonography (TVS). If the endometrium is ≥ 9 mm, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 9 mm, estradiol will be continued until reaching appropriate endometrial thickness and then the luteal phase support will be started. The cycle will be cancelled If the estradiol administration >60 days. | Drug | Control-HRT group |
Primary outcome
Ongoing pregnancy rate
Time frame: 10th week after embryo transfer
Ongoing pregnancy is defined as the presence of a gestational sac with foetal heartbeat by transvaginal ultrasound at 10th week after embryo transfer（ET）
5 secondary outcomes
Cycle cancellation rate
Time frame: the day of embryo transfer
Implantation rate
Time frame: 4th weeks after embryo transfer
Clinical pregnancy rate
Time frame: 4th weeks after embryo transfer
Early miscarriage rate
Time frame: 12th weeks gestational age
Biochemical pregnancy rate
Time frame: 4th weeks after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
Related trials for Infertility, Female
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human menopausal gonadotrophin and hormone replacement therapy in people with Infertility, Female and Intrauterine Adhesion, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ongoing pregnancy rate (time frame: 10th week after embryo transfer). 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 11 Jan 2022.