InfertilityLH/M2-OocyteNCT01595334
Study on Influence of Leutinizing Hormone (LH) on Oocyte Maturity
A study testing Cetrorelix and Luprolide Acetate in people with Infertility, run by Southern Cross Fertility Centre at 3 sites in India.
Trial summary
1. Leutinizing hormone (LH) has been demonstrated to exert variable physiological actions during menstrual cycle at appropriate plasma levels' 2. In early follicular phase,in the requisite range,LH is known to contribute to maturation of oocyte during transition phase from metaphase-1(M1) to metaphase-2 (M2). 3. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Cetrorelix and Luprolide Acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesIndia
- Study dates
- Apr 2012to Nov 2012
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-40 years
- Primary or secondary infertility
- Desire to achieve pregnancy
- Basal FSH <12 mIU/ML
- Moderate to good ovarian reserve (antimullerian hormone (AMH) >1ng/ml, and/ or antral follicle count (AFC)>8 between both ovaries)
- Informed written consent from both partners
- BMI <35 kg/mtr.sq.
- No genetic abnormality
Who cannot join
- Hormonal preparation taken within 3 month prior to recruitment
- Women with previous poor response to gonadotrophins
- History of previous 3 or more miscarriages
- Women with uncorrected tubal/uterine pathology
- Women opting for assisted procedures like embryo hatching etc.
Trial locations and contacts
3 sites in 1 country.
India3 sites, 3 recruiting
- Recruiting
Sat Kaival Hospital Pvt. Ltd.
Anand, Gujarat
Nayana Patel, MD
Nayana Patel;, MD
- Recruiting
Disha Fertility & Surgical Hospital
Indore, Madhya Pradesh
Asha Baxi, MD, FRCOG
Asha Baxi, MD, FRCOG
- Recruiting
Southern Cross Fertility Center
Mumbai, Maharashtra
Faram Irani, MD
Faram Irani, MD
About this study
Official title: Is it Possible to Obtain Higher Yield of Mature M2 Oocytes by Establishing Appropriate Levels of LH During Controlled Ovarian Hyperstimulation (COH) in Antagonist Cycles for In-vitro Fertilization-embryo Transfer (IVF-ET)/ Intracytoplasmic Sperm Injection (ICSI)?
- Leutinizing hormone (LH) has been demonstrated to exert variable physiological actions during menstrual cycle at appropriate plasma levels'
- In early follicular phase,in the requisite range,LH is known to contribute to maturation of oocyte during transition phase from metaphase-1(M1) to metaphase-2 (M2).
- If during this transition, appropriate level of LH can be maintained either through the use of gonadotropin releasing hormone (GnRH) antagonist if found excessive or supplementation with exogenous LH, if found deficient, maturation process can be enhanced.
- Further maintenance of suitable combination of recombinant follicle stimulating hormone (rFSH) + rLH can help in realizing higher yield of mature M2 oocytes,with higher probability of establishing clinical pregnancy.
Read the detailed description
The study is planned to assess whether maintenance of levels of LH through the use of GnRH antagonist would contribute to obtaining mature M2 oocytes so that maximum number of good quality embryo's with potential to implant is obtained.
The mature oocytes would be subjected to either standard in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) depending on the status of the male factor.
The objective would be to obtain good quality embryo's with implantation potential for fresh embryo transfer and/or subsequent frozen thaw embryo transfer.
In both these events, the secondary outcome measures would be establishment of clinical pregnancy by transvaginal ultrasound performed 6 weeks after embryo transfer.
- Conditions
- Infertility
- Being tested
- Cetrorelix, Luprolide Acetate
- Keywords
- IVF-ET, ICSI, Gonadotrophins, rFSH, rLH, Cetrorelix, Leuprolide acetate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetrorelixDrug
Also called Cetrotide
Cetrorelix 0.25 mg/d would be administered by subcutaneous injection to women when the plasma LH is higher (>4.5 mIU/ml) in the study arm
Luprolide AcetateDrug
Also called Lupron
Women in the control arm would receive Luprolide acetate 1 mg/day by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Study subjects desiring pregnancy | Active comparator | Study subjects to be treated with rFSH, rLH throughout controlled ovarian hyperstimulation (COH) in appropriate dosages,considering age, body mass index (BMI), ovarian reserve, etc. and GnRH antagonist, cetrorelix in 0.25 mg/d when needed till the desired follicular maturity and the minimum required number of follicles are achieved.
INTRVENTIONS - Monitoring at regular intervals by transvaginal ultrasound and hormonal studies.Once pregnancy established by beta-human chorionic gonadotropin (hCG) and ultrasound will be supported by intervention of adequate luteal support by estrogen (E) + progesterone (P) for 12 weeks of gestation. Receives: Drug: Cetrorelix |
| Control subjects desiring pregnancy | Other | Control subjects selected in randomized way,desiring pregnancy will be treated with gonadotrophins, rFSH and rLH in appropriate dosages considering age, BMI, ovarian reserve, etc. after standard downregulation with GnRH agonist, Leuprolide acetate, 1 mg/d under established 'Long Luteal Suppression Protocol' from the previous cycle.
INTERVENTIONS - Monitoring of response to treatment by hormonal study and sonography evaluation at regular intervals during COH till adequate number of mature follicles of minimum 18 mm mean diameter is achieved, to be followed by hCG trigger and ovum pick-up (OPU) and embryo transfer (ET). Chemical pregnancy by beta-hCG would be confirmed 14 days post-ET. Clinical pregnancy would be confirmed by sonography 6 weeks after ET (visibility of yolk sac and fetal heart-beat). Pregnancy support by E+P for 12 weeks would be provided. Receives: Drug: Luprolide Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mature oocytes immediately after oocyte recovery
Number of mature oocytes would be measured immediately after the oocyte recovery
Measured: Women would be followed every 2 weeks upto 6 weeks after embryo transfer
Secondary outcomes (1)
Clinical pregnancy
Diagnosed by transvaginal ultrasound.Appearance of yolk sac with fetal heart beat at 6 weeks of gestation.
Measured: Women would be followed every 2 weeks upto 6 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 posted10 May 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2012 (estimated)
- Study completionNov 2012 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Cross Fertility Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Disha Fertility and Surgical Centre,Indore,India
- Responsible party
- Sponsor
- Investigators
- M R Bharucha, PhD, Study director, Sat Kaival Pvt. Ltd, Anand, GujaratNayana Patel, MD, Principal investigator, Sat Kaival Hospital Pvt. Ltd, Anand, GuajaratFaram Irani, MD, Principal investigator, Southern Cross Fertility Center, Mumbai, IndiaAsha Baxi, MD, FRCOG, Principal investigator, Disha Fertility & Surgical Hospital, Indore, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595334
- Sponsor's protocol ID
- MB/LH-M2/OM/2011
- Acronym
- LH/M2-Oocyte
- Status last verified
- May 2012
- First submitted
- 27 Apr 2012
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Possible to Obtain Higher Yield of Mature M2 Oocytes by Establishing Appropriate Levels of LH During Controlled Ovarian Hyperstimulation (COH) in Antagonist Cycles for In-vitro Fertilization-embryo Transfer (IVF-ET)/ Intracytoplasmic Sperm Injection (ICSI)?
- ClinicalTrials.gov ID
- NCT01595334
- Acronym / sponsor ID
- LH/M2-Oocyte / MB/LH-M2/OM/2011
- Conditions
- Infertility
- Keywords
- IVF-ET, ICSI, Gonadotrophins, rFSH, rLH, Cetrorelix, Leuprolide acetate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Southern Cross Fertility CentreUniversity, hospital or other
- Collaborators
- Disha Fertility and Surgical Centre,Indore,India
- Study start
- Apr 2012
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 10 May 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.
- Leutinizing hormone (LH) has been demonstrated to exert variable physiological actions during menstrual cycle at appropriate plasma levels'
- In early follicular phase,in the requisite range,LH is known to contribute to maturation of oocyte during transition phase from metaphase-1(M1) to metaphase-2 (M2).
- If during this transition, appropriate level of LH can be maintained either through the use of gonadotropin releasing hormone (GnRH) antagonist if found excessive or supplementation with exogenous LH, if found deficient, maturation process can be enhanced.
- Further maintenance of suitable combination of recombinant follicle stimulating hormone (rFSH) + rLH can help in realizing higher yield of mature M2 oocytes,with higher probability of establishing clinical pregnancy.
Detailed description
The study is planned to assess whether maintenance of levels of LH through the use of GnRH antagonist would contribute to obtaining mature M2 oocytes so that maximum number of good quality embryo's with potential to implant is obtained.
The mature oocytes would be subjected to either standard in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) depending on the status of the male factor.
The objective would be to obtain good quality embryo's with implantation potential for fresh embryo transfer and/or subsequent frozen thaw embryo transfer.
In both these events, the secondary outcome measures would be establishment of clinical pregnancy by transvaginal ultrasound performed 6 weeks after embryo transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study subjects desiring pregnancy | Active comparator | Drug: CetrorelixStudy subjects to be treated with rFSH, rLH throughout controlled ovarian hyperstimulation (COH) in appropriate dosages,considering age, body mass index (BMI), ovarian reserve, etc. and GnRH antagonist, cetrorelix in 0.25 mg/d when needed till the desired follicular maturity and the minimum required number of follicles are achieved. INTRVENTIONS - Monitoring at regular intervals by transvaginal ultrasound and hormonal studies.Once pregnancy established by beta-human chorionic gonadotropin (hCG) and ultrasound will be supported by intervention of adequate luteal support by estrogen (E) + progesterone (P) for 12 weeks of gestation. |
| Control subjects desiring pregnancy | Other | Drug: Luprolide AcetateControl subjects selected in randomized way,desiring pregnancy will be treated with gonadotrophins, rFSH and rLH in appropriate dosages considering age, BMI, ovarian reserve, etc. after standard downregulation with GnRH agonist, Leuprolide acetate, 1 mg/d under established 'Long Luteal Suppression Protocol' from the previous cycle. INTERVENTIONS - Monitoring of response to treatment by hormonal study and sonography evaluation at regular intervals during COH till adequate number of mature follicles of minimum 18 mm mean diameter is achieved, to be followed by hCG trigger and ovum pick-up (OPU) and embryo transfer (ET). Chemical pregnancy by beta-hCG would be confirmed 14 days post-ET. Clinical pregnancy would be confirmed by sonography 6 weeks after ET (visibility of yolk sac and fetal heart-beat). Pregnancy support by E+P for 12 weeks would be provided. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women aged 18-40 years
- Primary or secondary infertility
- Desire to achieve pregnancy
- Basal FSH <12 mIU/ML
- Moderate to good ovarian reserve (antimullerian hormone (AMH) >1ng/ml, and/ or antral follicle count (AFC)>8 between both ovaries)
Key exclusion criteria (5 listed)
- Hormonal preparation taken within 3 month prior to recruitment
- Women with previous poor response to gonadotrophins
- History of previous 3 or more miscarriages
- Women with uncorrected tubal/uterine pathology
- Women opting for assisted procedures like embryo hatching etc.
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 |
|---|---|---|
| CetrorelixAlso: CetrotideCetrorelix 0.25 mg/d would be administered by subcutaneous injection to women when the plasma LH is higher (>4.5 mIU/ml) in the study arm | Drug | Study subjects desiring pregnancy |
| Luprolide AcetateAlso: LupronWomen in the control arm would receive Luprolide acetate 1 mg/day by subcutaneous injection | Drug | Control subjects desiring pregnancy |
Primary outcome
Number of mature oocytes immediately after oocyte recovery
Time frame: Women would be followed every 2 weeks upto 6 weeks after embryo transfer
Number of mature oocytes would be measured immediately after the oocyte recovery
1 secondary outcome
Clinical pregnancy
Time frame: Women would be followed every 2 weeks upto 6 weeks after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2012.
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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.
M R Bharucha, PhD study director
Sat Kaival Pvt. Ltd, Anand, Gujarat
Nayana Patel, MD principal investigator
Sat Kaival Hospital Pvt. Ltd, Anand, Guajarat
Faram Irani, MD principal investigator
Southern Cross Fertility Center, Mumbai, India
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cetrorelix and Luprolide Acetate in people with Infertility, run by Southern Cross Fertility Centre at 3 sites in India.
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 8 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: status not confirmed, as of the sponsor's last update on 25 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. 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 Manchi Bharucha, Ph.D. (91-9892211941, drmanchi41@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of mature oocytes immediately after oocyte recovery (time frame: Women would be followed every 2 weeks upto 6 weeks 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 25 May 2012.