Infertility,FemaleNCT04178135
Recombinant LH Supplementation Timing Strategies (From Day 1 or Day 6) to a Standard GnRH Agonist Long Protocol in Subsequent COS Cycle of Older Patients With Unexpected Poor or Suboptimal Ovarian Response
A study testing rLH in people with Infertility,Female, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 2 sites in China.
Trial summary
A randomized, controlled, pilot study, for Patients ≥ 35 years and < 40 years old with sufficient ovarian reserve parameters (AFC≥ 5), but showed an unexpected poor or suboptimal ovarian response(defined as ≤ 9 retrieved oocytes in previous full-stimulation cycle, but not get live birth after all embryos were used ). Read more about this study
- Who is it for?
- Ages 35 months to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility,Female
- What is being tested?
- rLH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 25 Dec 2019to 30 Dec 2022
- 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 35 months to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1.Infertile women, 35≤ Age< 40 years 2.18<BMI<28 Kg/m2 3.5 ≤AFC ≤20 4.Basal serum FSH≤10 IU/L, E2<70 pg/ml 5.Previous cycle as the first COS cycle,AFC ≥ 5,starting dose of FSH between 150 IU and 300IU with the possibility of adding r-hLH or hMG later in the cycle, number of oocytes retrieved ≤9 (4-9 oocytes retrieval as suboptimal responder and <4 oocytes retrieval as unexpected poor responder), but not get live birth after all embryos were used.
- 6.Normal uterus and at least one side of the normal ovary 7.GnRH-a long protocol, using Gonal-F® 300IU and Luveris® 150IU for COS 8.Informed consent form signed 9.Willing to follow the study protocol, and able to complete this study
Who cannot join
- Moderate and Severe endometriosis
- PCOS
- Previous ovarian surgery history
- History of recurrent miscarriages (>2 times of miscarriages)
- Any major systemic disease that as per Investigator's discretion precludes subject for participation in the study
- With pregnancy contraindications Alcoholism, drug abuse, drug addiction or patients with uncured sexually transmitted disease
Show all 9Show fewer
- According to the judgment of the Investigator, any medical condition or any concomitant surgery/medications that would interfere with evaluation of study medications
- Simultaneous participation in another clinical study
- Plan to use other Gn other than Gonal-F® or Luveris® during COS treatment Thyroid gland disorders
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, 410000
Sufen Cai, doctor, 0731-82355100, ajiu0305@163.com
- Recruiting
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, 410008
Sufen Cai, doctor, 0731-82355100, ajiu0305@163.com
About this study
A randomized, controlled, pilot study, for Patients ≥ 35 years and < 40 years old with sufficient ovarian reserve parameters (AFC≥ 5), but showed an unexpected poor or suboptimal ovarian response(defined as ≤ 9 retrieved oocytes in previous full-stimulation cycle, but not get live birth after all embryos were used ). In order to get better oocyte number and quality in the new COS cycle, we will compare LH supplementation from beginning with from middle of stimulation in GnRH-a long protocol.
- Conditions
- Infertility,Female
- Being tested
- rLH
- Keywords
- poor or suboptimal ovarian response,GnRH agonist long protocol
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rLHDrug
rLH supplement from day 1 of stimulation
rLHDrug
rLH supplement from day 6 of stimulation
| Study group | Role | What they receive |
|---|---|---|
| rLH supplementation from day 1 of stimulation | Experimental | rLH supplementation from day 1 of stimulation Receives: Drug: rLH |
| rLH supplementation from day 6 of stimulation | Active comparator | rLH supplementation from day 6 of stimulation Receives: Drug: rLH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of gestational sacs
Number of gestation sac will be detected by ultrasonographic visualization
Measured: Day 28 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 posted26 Nov 2019
- Study start25 Dec 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sufen Cai, Doctor, Principal investigator, Reproductive and Genetic hospital of CITIC-xiangya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178135
- Sponsor's protocol ID
- P2019005
- Status last verified
- Jan 2022
- First submitted
- 24 Nov 2019
- 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
- Recombinant LH Supplementation Timing Strategies (From Day 1 or Day 6) to a Standard GnRH Agonist Long Protocol in Subsequent COS Cycle of Older Patients With Unexpected Poor or Suboptimal Ovarian Response
- ClinicalTrials.gov ID
- NCT04178135
- Acronym / sponsor ID
- P2019005
- Conditions
- Infertility,Female
- Keywords
- poor or suboptimal ovarian response,GnRH agonist long protocol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Study start
- 25 Dec 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 26 Nov 2019 (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.
A randomized, controlled, pilot study, for Patients ≥ 35 years and < 40 years old with sufficient ovarian reserve parameters (AFC≥ 5), but showed an unexpected poor or suboptimal ovarian response(defined as ≤ 9 retrieved oocytes in previous full-stimulation cycle, but not get live birth after all embryos were used ). In order to get better oocyte number and quality in the new COS cycle, we will compare LH supplementation from beginning with from middle of stimulation in GnRH-a long protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rLH supplementation from day 1 of stimulation | Experimental | Drug: rLHrLH supplementation from day 1 of stimulation |
| rLH supplementation from day 6 of stimulation | Active comparator | Drug: rLHrLH supplementation from day 6 of stimulation |
Who may qualify
- Ages
- 35 months to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 1.Infertile women, 35≤ Age< 40 years 2.18<BMI<28 Kg/m2 3.5 ≤AFC ≤20 4.Basal serum FSH≤10 IU/L, E2<70 pg/ml 5.Previous cycle as the first COS cycle,AFC ≥ 5,starting dose of FSH between 150 IU and 300IU with the possibility of adding r-hLH or hMG later in the cycle, number of oocytes retrieved ≤9 (4-9 oocytes retrieval as suboptimal responder and <4 oocytes retrieval as unexpected poor responder), but not get live birth after all embryos were used.
- 6.Normal uterus and at least one side of the normal ovary 7.GnRH-a long protocol, using Gonal-F® 300IU and Luveris® 150IU for COS 8.Informed consent form signed 9.Willing to follow the study protocol, and able to complete this study
Key exclusion criteria (9 listed)
- Moderate and Severe endometriosis
- PCOS
- Previous ovarian surgery history
- History of recurrent miscarriages (>2 times of miscarriages)
- Any major systemic disease that as per Investigator's discretion precludes subject for participation in the study
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 |
|---|---|---|
| rLHrLH supplement from day 1 of stimulation | Drug | rLH supplementation from day 1 of stimulation |
| rLHrLH supplement from day 6 of stimulation | Drug | rLH supplementation from day 6 of stimulation |
Primary outcome
Number of gestational sacs
Time frame: Day 28 after embryo transfer
Number of gestation sac will be detected by ultrasonographic visualization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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. This study is not recruiting at the moment.
Sufen Cai, Doctor principal investigator
Reproductive and Genetic hospital of CITIC-xiangya
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rLH in people with Infertility,Female, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 2 sites 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 2 inclusion and 9 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: status not confirmed, 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 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sufen Cai, Doctor (0731-82355100, ajiu0305@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of gestational sacs (time frame: Day 28 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.