InfertilityPhase 4PORNCT01926210
Comparison of Ovarian Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders
A Phase 4 study testing mild stimulation protocol in people with Infertility, run by Huang Rui at 1 site in China.
Trial summary
This is a prospective, randomized clinical trial to compare the efficiency and safety of mild stimulation and controlled ovarian stimulation protocol on the treatment of POR. The randomization is achieved on the basis of a computer-generated randomization list in a 1:1 ratio. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- mild stimulation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Sep 2016
- Phase
- Phase 4
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- a. Poor ovarian responders b. Normal BMI (18-25 Kg/m2) c. Regular menstruation (with cycle 23-35 days)
Who cannot join
- a. History of repeated IVF failure (previous IVF cycle >2) b. Serious adenomyosis c. Polycystic ovary syndrome(PCOS) patients d. History of allergic to ovulation induction medicines e. Abnormal uterine cavity, i.e, intrauterine adhesion f. Attending other clinical trials in the same period. g. History of systemic disease contradictory to COH or pregnancy.
Trial locations and contacts
1 site in 1 country.
Xing Yang, M.D. contact
China1 site
sixth affiliated hospital of Sun Yet-san University
Guangzhou, Guangdong, 510010
Yu Deng, M.D., dengyu1983@yahoo.com.cn
Rui Huang, M.D.
About this study
Official title: The Comparison of Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders: a Prospective Randomized Study.
This is a prospective, randomized clinical trial to compare the efficiency and safety of mild stimulation and controlled ovarian stimulation protocol on the treatment of POR. The randomization is achieved on the basis of a computer-generated randomization list in a 1:1 ratio.
Read the detailed description
500 poor ovarian responders will be equally randomized to two different ovarian stimulation protocol arms,i.e, mild ovarian stimulation(experimental arm) or controlled ovarian stimulation(control arm). In experimental arm, patients will received letrozole 5mg per day from cycle day 3 to 7 and recombinant follicle-stimulating hormone (FSH) 150 international unit (IU) on day 4 and 6. The dose of recombinant FSH is adjusted according to the ovarian response and the gonadotropin-releasing hormone(GnRH)antagonist(Cetrotide) 0.25mg per day is administrated when the estradiol level reaches 200 pg/ml and the serum luteinizing hormone （LH）level rises above 2 times of basal LH level. In control arm,patients will be stimulated with short-acting GnRH agonist long protocol. After complete downregulation is achieved through GnRH-agonist, recombinant FSH 300 IU/d is given for 5 days, then the dose of recombinant FSH is adjusted according to ovarian response.
The clinical and ongoing pregnancy rate and other secondary outcome parameters are compared between these two groups.
- Conditions
- Infertility
- Being tested
- mild stimulation protocol, controlled ovarian stimulation
- Keywords
- Poor ovarian response, in vitro fertilization, mild ovarian stimulation, controlled ovarian stimulation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mild stimulation protocolOther
Also called letrozole, recombinant FSH, GnRH antagonist
letrozole is used from cycle day 3 to 7 and low dose recombinant FSH(no more than 150 IU/d) is used on cycle day 4,6 and 8 onwards. GnRH antagonist is only applied in case of premature LH rise might happen.
controlled ovarian stimulationOther
Also called GnRH agonist, recombinant FSH
After fully downregulation by using short-acting GnRH agonist, 300 IU/d recombinant FSH is administrated for 5 days, then the dose is adjusted according to ovarian response.
| Study group | Role | What they receive |
|---|---|---|
| mild ovarian stimulation | Experimental | Patients are stimulated with mild ovarian stimulation protocol,i.ed, from cycle day 3 to 7, letrozole 5mg per day are administrated and recombinant FSH 150 IU are given on day 4 and 6 . On cycle day 8, serum FSH LH, and estradiol levels are measured, and after then, the dose of recombinant FSH is adjusted according to the ovarian response and the maxim recombinant FSH dose is 150 IU/d. The GnRH-antagonist (Cetrotide) 0.25mg per day is administrated when the estradiol level reaches 200 pg/ml and the serum LH level rises above 2 times of basal LH level. Receives: Other: mild stimulation protocol |
| controlled ovarian stimulation | Active comparator | Patients are stimulated using controlled ovarian stimulation protocol,i.e., from cycle day 18-22 (day 7 after ovulation) of previous cycle, all participants are given short-acting GnRH agonist (Triptorelin 0.05mg/d) for 14 days, then after checking serum FSH, LH and estradiol to make sure that complete downregulation is achieved, exogenous gonadotropin (recombinant FSH) 300 IU/d is given for 5 days, then the dose of recombinant FSH is adjusted according to ovarian response. Receives: Other: controlled ovarian stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
Measured: 7 weeks
Secondary outcomes (19)
live birth rate
Measured: 10 months
Number of oocytes retrieved
Measured: 3 weeks
Number of transferrable embryo
Measured: 3 weeks
normal fertilization rate
Measured: 3 weeks
implantation rate
Measured: 7 weeks
ongoing pregnancy rate
Measured: 3 months
Total dose of recombinant FSH consumption
Measured: 3 weeks
length of stimulation
Measured: 3 weeks
serum estradiol level
Measured: 3 weeks
serum LH level
Measured: 3 weeks
serum progesterone level
Measured: 3 weeks
serum FSH level
Measured: 3 weeks
FSH level in follicular fluid
Measured: 3 weeks
LH level in follicular fluid
Measured: 3 weeks
Estradiol level in the follicular fluid
Measured: 3 weeks
progesterone level in follicular fluid
Measured: 3 weeks
testerone level in the follicular fluid
Measured: 3 weeks
anti-müllerian hormone (AMH)level in follicular fluid
Measured: 3 weeks
Ovarian Hyperstimulation Syndrome (OHSS) rate
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2015 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huang Rui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huang Rui, Sun Yat-sen University
- Investigators
- Rui Huang, M.D., Principal investigator, sixth affiliated hospital of Sun Yet-san University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926210
- Sponsor's protocol ID
- A-2013-01-05S
- Acronym
- POR
- Status last verified
- Aug 2013
- First submitted
- 14 Aug 2013
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders: a Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT01926210
- Acronym / sponsor ID
- POR / A-2013-01-05S
- Conditions
- Infertility
- Keywords
- Poor ovarian response, in vitro fertilization, mild ovarian stimulation, controlled ovarian stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Huang RuiUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 20 Aug 2013 (estimated)
- 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 is a prospective, randomized clinical trial to compare the efficiency and safety of mild stimulation and controlled ovarian stimulation protocol on the treatment of POR. The randomization is achieved on the basis of a computer-generated randomization list in a 1:1 ratio.
Detailed description
500 poor ovarian responders will be equally randomized to two different ovarian stimulation protocol arms,i.e, mild ovarian stimulation(experimental arm) or controlled ovarian stimulation(control arm). In experimental arm, patients will received letrozole 5mg per day from cycle day 3 to 7 and recombinant follicle-stimulating hormone (FSH) 150 international unit (IU) on day 4 and 6. The dose of recombinant FSH is adjusted according to the ovarian response and the gonadotropin-releasing hormone(GnRH)antagonist(Cetrotide) 0.25mg per day is administrated when the estradiol level reaches 200 pg/ml and the serum luteinizing hormone （LH）level rises above 2 times of basal LH level. In control arm,patients will be stimulated with short-acting GnRH agonist long protocol. After complete downregulation is achieved through GnRH-agonist, recombinant FSH 300 IU/d is given for 5 days, then the dose of recombinant FSH is adjusted according to ovarian response.
The clinical and ongoing pregnancy rate and other secondary outcome parameters are compared between these two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild ovarian stimulation | Experimental | Other: mild stimulation protocolPatients are stimulated with mild ovarian stimulation protocol,i.ed, from cycle day 3 to 7, letrozole 5mg per day are administrated and recombinant FSH 150 IU are given on day 4 and 6 . On cycle day 8, serum FSH LH, and estradiol levels are measured, and after then, the dose of recombinant FSH is adjusted according to the ovarian response and the maxim recombinant FSH dose is 150 IU/d. The GnRH-antagonist (Cetrotide) 0.25mg per day is administrated when the estradiol level reaches 200 pg/ml and the serum LH level rises above 2 times of basal LH level. |
| controlled ovarian stimulation | Active comparator | Other: controlled ovarian stimulationPatients are stimulated using controlled ovarian stimulation protocol,i.e., from cycle day 18-22 (day 7 after ovulation) of previous cycle, all participants are given short-acting GnRH agonist (Triptorelin 0.05mg/d) for 14 days, then after checking serum FSH, LH and estradiol to make sure that complete downregulation is achieved, exogenous gonadotropin (recombinant FSH) 300 IU/d is given for 5 days, then the dose of recombinant FSH is adjusted according to ovarian response. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- a. Poor ovarian responders b. Normal BMI (18-25 Kg/m2) c. Regular menstruation (with cycle 23-35 days)
Key exclusion criteria (1 listed)
- a. History of repeated IVF failure (previous IVF cycle >2) b. Serious adenomyosis c. Polycystic ovary syndrome(PCOS) patients d. History of allergic to ovulation induction medicines e. Abnormal uterine cavity, i.e, intrauterine adhesion f. Attending other clinical trials in the same period. g. History of systemic disease contradictory to COH or pregnancy.
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 |
|---|---|---|
| mild stimulation protocolAlso: letrozole, recombinant FSH, GnRH antagonistletrozole is used from cycle day 3 to 7 and low dose recombinant FSH(no more than 150 IU/d) is used on cycle day 4,6 and 8 onwards. GnRH antagonist is only applied in case of premature LH rise might happen. | Other | mild ovarian stimulation |
| controlled ovarian stimulationAlso: GnRH agonist, recombinant FSHAfter fully downregulation by using short-acting GnRH agonist, 300 IU/d recombinant FSH is administrated for 5 days, then the dose is adjusted according to ovarian response. | Other | controlled ovarian stimulation |
Primary outcome
clinical pregnancy rate
Time frame: 7 weeks
19 secondary outcomes
live birth rate
Time frame: 10 months
Number of oocytes retrieved
Time frame: 3 weeks
Number of transferrable embryo
Time frame: 3 weeks
normal fertilization rate
Time frame: 3 weeks
implantation rate
Time frame: 7 weeks
ongoing pregnancy rate
Time frame: 3 months
Total dose of recombinant FSH consumption
Time frame: 3 weeks
length of stimulation
Time frame: 3 weeks
serum estradiol level
Time frame: 3 weeks
serum LH level
Time frame: 3 weeks
serum progesterone level
Time frame: 3 weeks
serum FSH level
Time frame: 3 weeks
FSH level in follicular fluid
Time frame: 3 weeks
LH level in follicular fluid
Time frame: 3 weeks
Estradiol level in the follicular fluid
Time frame: 3 weeks
progesterone level in follicular fluid
Time frame: 3 weeks
testerone level in the follicular fluid
Time frame: 3 weeks
anti-müllerian hormone (AMH)level in follicular fluid
Time frame: 3 weeks
Ovarian Hyperstimulation Syndrome (OHSS) rate
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
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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.
Xing Yang, M.D. contact
Rui Huang, M.D. principal investigator
sixth affiliated hospital of Sun Yet-san University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mild stimulation protocol in people with Infertility, run by Huang Rui 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 1 inclusion and 1 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 21 Aug 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xing Yang, M.D. (yxing8358@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate (time frame: 7 weeks). 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 21 Aug 2013.