InfertilityPhase 3NCT01509833
Efficacy of Low Dose hCG on Oocyte Maturity in Poor Responder Women Undergoing Intracytoplasmic Sperm Injection
A Phase 3 study testing rFSH and hCG in people with Infertility, run by Royan Institute at 1 site in Iran.
Trial summary
This study is a prospective, randomized, parallel, controlled trial to assess the efficacy of the late follicular phase administration of low dose hCG on oocyte maturity for ovarian stimulation in 73 poor respond patients undergoing intracytoplasmic sperm injection (ICSI) treatment. Read more about this study
- Who is it for?
- Ages 37 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- rFSH and hCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteIran
- Study dates
- Oct 2009to Dec 2011
- Phase
- Phase 3
- 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 37 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Poor ovarian response to ovulation induction according to the ESHRE definition[20] and presence of at least 2 of the criteria needed to define poor responders including advanced maternal age, history of low ovarian response in previous IVF/ICSI treatments and abnormal ovarian reserve test(Antral Follicle number < 5)
- indication for ICSI treatment, second or third cycle
- Age 37 to 43 years
- Body mass index (BMI) ≤ 30 kg/m2
- The presence of two functional ovaries and no previous ovarian surgery
- The presence of normal uterine cavity and 2 normal tubes base on recent hysterosalpingographic or hysteroscopic evaluation
Show all 10Show fewer
- Basal (day 2 or 3) serum FSH levels ≤13 IU/L
- Normal semen analysis
- No history or signs of endometriosis
- No untreated endocrinologic disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Low Dose hCG on Oocyte Maturity for Ovarian Stimulation in Poor Responder Women Undergoing ICSI: a Prospective Randomized Controlled Trial
This study is a prospective, randomized, parallel, controlled trial to assess the efficacy of the late follicular phase administration of low dose hCG on oocyte maturity for ovarian stimulation in 73 poor respond patients undergoing intracytoplasmic sperm injection (ICSI) treatment.
Read the detailed description
In this study all eligible patients were randomly allocated into three study groups by a permuted block randomization method: group A (control group) received only recombinant FSH, group B received rFSH supplemented by 100IU hCG in the late follicular phase. Group C received rFSH supplemented by 200IU hCG in the late follicular phase.
All of the patients underwent a standard long protocol and received GnRH-a (Suprefact), 0.5cc subcutaneous, started from the day 17 of the preceding cycle and ovulation induction was started 14 days thereafter.
Patients were categorized according to the following stimulation protocols:
Group A (control group): which 300 IU r-FSH was administered for the first 5 days of the stimulation cycle. Then the first ultrasound scan was performed to monitor response. At this stage the dose of rFSH adjusted according to the ovarian response and continued until the day of ovulatory hCG administration.
Group B: rFSH supplemented with daily administration of 100 IU hCG in the late follicular phase based on the follicle size (14mm).
Group C: rFSH supplemented with daily administration of 200 IU hCG in the late follicular phase based on the follicle size (14mm).
To assess the pregnancy outcomes, serum hCG was measured 2 weeks after embryo transfer. Clinical pregnancy was defined by the observation of sac with fetal heart rate on ultrasonography 4 weeks after embryo transfer.
- Conditions
- Infertility
- Being tested
- rFSH, hCG
- Keywords
- ICSI Ovarian stimulation, hCG low dose, Oocyte maturity, poor respond
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rFSHDrug
Administration of rFSH for ovarian stimulation.
hCGDrug
Administration of late follicular low dose hCG(100IU) for ovarian stimulation.
hCGDrug
Administration of late follicular low dose hCG(200IU) for ovarian stimulation.
| Study group | Role | What they receive |
|---|---|---|
| rFSH | Experimental | Administration of recombinant FSH for ovarian stimulation. Receives: Drug: rFSH |
| hCG(100IU) | Experimental | Administration of late follicular low dose hCG(100U) for ovarian stimulation. Receives: Drug: hCG |
| hCG(200IU) | Experimental | Administration of late follicular low dose hCG(200IU) for ovarian stimulation. Receives: Drug: hCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mature oocytes
Evaluation the number of mature oocytes Up to 2 hours after oocyte retrieval
Measured: Up to 2 hours after oocyte retrieval
Secondary outcomes (8)
Number of retrieved oocytes
Evaluation the number of retrieved oocytes Up to 1 hour after oocyte retrieval
Measured: Up to 1 hour after oocyte retrieval
Number of generated embryos
Evaluation the number of generated embryos up to 48-72 hours after oocyte retrieval.
Measured: Up to 48-72 hours after oocyte retrieval
Quality of generated embryos
Evaluation the Quality of generated embryos up to 48-72 hours after oocyte retrieval.
Measured: Up to 48-72 hours after oocyte retrieval
Number of transferred embryos
Evaluation the number of transferred embryos on the time of embryo transfer.
Measured: on the time of embryo transfer
Quality of transferred embryos
Evaluation the quality of transferred embryos on the time of embryo transfer.
Measured: on the time of embryo transfer
implantation rate
Evaluation the implantation rate 4 weeks after embryo transfer.
Measured: 4 weeks after embryo transfer
chemical pregnancy rates
Evaluation the chemical pregnancy rates 2 weeks after embryo transfer.
Measured: 2 weeks after embryo transfer
clinical pregnancy rates
Evaluation the clinical pregnancy rates 4 weeks after embryo transfer.
Measured: 4 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 posted13 Jan 2012 (estimated)
- Study startOct 2009
- Primary completionMar 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteTahereh Madani, MD, Study director, scientistLadan Mohmmadi yeganeh, MSc, Principal investigator, scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509833
- Sponsor's protocol ID
- Royan-Emb-013
- Status last verified
- Aug 2009
- First submitted
- 5 Jan 2012
- Last updated
- 13 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Madani T, Mohammadi Yeganeh L, Khodabakhshi S, Akhoond MR, Hasani F. Efficacy of low dose hCG on oocyte maturity for ovarian stimulation in poor responder women undergoing intracytoplasmic sperm injection cycle: a randomized controlled trial. J Assist Reprod Genet. 2012 Nov;29(11):1213-20. doi: 10.1007/s10815-012-9854-3. Epub 2012 Sep 7.
PubMed 22956348
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low Dose hCG on Oocyte Maturity for Ovarian Stimulation in Poor Responder Women Undergoing ICSI: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01509833
- Acronym / sponsor ID
- Royan-Emb-013
- Conditions
- Infertility
- Keywords
- ICSI Ovarian stimulation, hCG low dose, Oocyte maturity, poor respond
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Oct 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Jan 2012 (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 study is a prospective, randomized, parallel, controlled trial to assess the efficacy of the late follicular phase administration of low dose hCG on oocyte maturity for ovarian stimulation in 73 poor respond patients undergoing intracytoplasmic sperm injection (ICSI) treatment.
Detailed description
In this study all eligible patients were randomly allocated into three study groups by a permuted block randomization method: group A (control group) received only recombinant FSH, group B received rFSH supplemented by 100IU hCG in the late follicular phase. Group C received rFSH supplemented by 200IU hCG in the late follicular phase.
All of the patients underwent a standard long protocol and received GnRH-a (Suprefact), 0.5cc subcutaneous, started from the day 17 of the preceding cycle and ovulation induction was started 14 days thereafter.
Patients were categorized according to the following stimulation protocols:
Group A (control group): which 300 IU r-FSH was administered for the first 5 days of the stimulation cycle. Then the first ultrasound scan was performed to monitor response. At this stage the dose of rFSH adjusted according to the ovarian response and continued until the day of ovulatory hCG administration.
Group B: rFSH supplemented with daily administration of 100 IU hCG in the late follicular phase based on the follicle size (14mm).
Group C: rFSH supplemented with daily administration of 200 IU hCG in the late follicular phase based on the follicle size (14mm).
To assess the pregnancy outcomes, serum hCG was measured 2 weeks after embryo transfer. Clinical pregnancy was defined by the observation of sac with fetal heart rate on ultrasonography 4 weeks after embryo transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rFSH | Experimental | Drug: rFSHAdministration of recombinant FSH for ovarian stimulation. |
| hCG(100IU) | Experimental | Drug: hCGAdministration of late follicular low dose hCG(100U) for ovarian stimulation. |
| hCG(200IU) | Experimental | Drug: hCGAdministration of late follicular low dose hCG(200IU) for ovarian stimulation. |
Who may qualify
- Ages
- 37 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Poor ovarian response to ovulation induction according to the ESHRE definition[20] and presence of at least 2 of the criteria needed to define poor responders including advanced maternal age, history of low ovarian response in previous IVF/ICSI treatments and abnormal ovarian reserve test(Antral Follicle number < 5)
- indication for ICSI treatment, second or third cycle
- Age 37 to 43 years
- Body mass index (BMI) ≤ 30 kg/m2
- The presence of two functional ovaries and no previous ovarian surgery
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| rFSHAdministration of rFSH for ovarian stimulation. | Drug | rFSH |
| hCGAdministration of late follicular low dose hCG(100IU) for ovarian stimulation. | Drug | hCG(100IU) |
| hCGAdministration of late follicular low dose hCG(200IU) for ovarian stimulation. | Drug | hCG(200IU) |
Primary outcome
Number of mature oocytes
Time frame: Up to 2 hours after oocyte retrieval
Evaluation the number of mature oocytes Up to 2 hours after oocyte retrieval
8 secondary outcomes
Number of retrieved oocytes
Time frame: Up to 1 hour after oocyte retrieval
Number of generated embryos
Time frame: Up to 48-72 hours after oocyte retrieval
Quality of generated embryos
Time frame: Up to 48-72 hours after oocyte retrieval
Number of transferred embryos
Time frame: on the time of embryo transfer
Quality of transferred embryos
Time frame: on the time of embryo transfer
implantation rate
Time frame: 4 weeks after embryo transfer
chemical pregnancy rates
Time frame: 2 weeks after embryo transfer
clinical pregnancy rates
Time frame: 4 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 13 Jan 2012.
- Derived from this study: PubMed 22956348Madani T, Mohammadi Yeganeh L, Khodabakhshi S, Akhoond MR, Hasani F. Efficacy of low dose hCG on oocyte maturity for ovarian stimulation in poor responder women undergoing intracytoplasmic sperm injection cycle: a randomized controlled trial. J Assist Reprod Genet. 2012 Nov;29(11):1213-20. doi: 10.1007/s10815-012-9854-3. Epub 2012 Sep 7.
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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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Tahereh Madani, MD study director
scientist
Ladan Mohmmadi yeganeh, MSc principal investigator
scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rFSH and hCG in people with Infertility, run by Royan Institute at 1 site in Iran.
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 10 inclusion and 0 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 13 Jan 2012. 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 Iran. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of mature oocytes (time frame: Up to 2 hours after oocyte retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01509833, which also lists 1 linked publication.
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 13 Jan 2012.