Unexplained InfertilityPhase 4NCT01237535
Luteal Phase Support With Progesterone Versus Estrogen and Progesterone on Pregnancy Rates
A Phase 4 study testing Luteal support with progesterone only, Luteal support with estrogen + progesterone and Insemination without luteal support in people with Unexplained Infertility and Mild Male Factor, run by Rabin Medical Center at 1 site in Israel.
Trial summary
This is a single center, 3 arms, prospective randomized controlled open study to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor. Patients will be randomized into 3 groups: 1. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Unexplained Infertility, Mild Male Factor
- What is being tested?
- Luteal support with progesterone only, Luteal support with estrogen + progesterone and Insemination without luteal support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2011to Nov 2013
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Couples with diagnosis of unexplained infertility
- In their treatment cycle with ovarian stimulation and IUI using recombinant FSH in our institution.
Who cannot join
- female partners with one or more of the following:
- previous ovarian surgery
- one ovary
- polycystic ovaries on ultrasound examination
- other endocrine abnormalities (i.e., polycystic ovarian syndrome, thyroid disorders,hyperprolactinemia,6.hypogonadotropic hypogonadism)
- past ovarian hyperstimulation or hyperstimulation during the study period
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- diminished ovarian reserve (basal FSH level >15 IU/mL)
- age of >40 years
- sever male factor < 5 million total motile sperm on the day of insemination.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rabin Medical Center
Petah Tikva, 49202
Galia Oron, Dr, 972-3-9377492, orong@clalit.org.il
Galia Oron, Dr
About this study
Official title: Luteal Phase Support With Progesterone vs Estrogen and Progesterone on Pregnancy Rates in Ovarian Stimulation and Intrauterine Insemination Cycles: a Prospective Randomized Study
This is a single center, 3 arms, prospective randomized controlled open study to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor.
Patients will be randomized into 3 groups:
- Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)
- Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].
- No luteal support
Read the detailed description
Study design:
single center, 3 arms, prospective randomized controlled open study
Objective:
to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor.
Methods:
All patients in all study groups will undergo a single insemination procedure and then will be randomized into 3 groups:
- Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)
- Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].
- No luteal support
Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived. A pregnancy test will be performed 2 weeks after insemination (Serum hCG) an intrauterine pregnancy will be confirmed using a transvaginal ultrasound 2 weeks after a positive pregnancy test. If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
- Conditions
- Unexplained Infertility, Mild Male Factor
- Being tested
- Luteal support with progesterone only, Luteal support with estrogen + progesterone, Insemination without luteal support
- Keywords
- Unexplained infertility, Insemination, Luteal phase support, Ovarian stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luteal support with progesterone onlyDrug
Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel).Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
Luteal support with estrogen + progesteroneDrug
Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
Insemination without luteal supportProcedure or surgery
Routine insemination procedure without luteal support
| Study group | Role | What they receive |
|---|---|---|
| Luteal support with progesterone only | Experimental | Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived. Receives: Drug: Luteal support with progesterone only |
| Luteal support with estrogen + progesterone | Experimental | Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg]. Receives: Drug: Luteal support with estrogen + progesterone |
| No luteal support | No intervention | Not described Receives: Procedure: Insemination without luteal support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy
A pregnancy test will be performed 2 weeks after insemination (Serum hCG) an intrauterine pregnancy will be confirmed using a transvaginal ultrasound 2 weeks after a positive pregnancy test
Measured: 4 weeks after insemintation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startNov 2011
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Galia Oron, Dr, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237535
- Sponsor's protocol ID
- rmc005788ctil
- Status last verified
- Nov 2010
- First submitted
- 8 Nov 2010
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Luteal Phase Support With Progesterone vs Estrogen and Progesterone on Pregnancy Rates in Ovarian Stimulation and Intrauterine Insemination Cycles: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01237535
- Acronym / sponsor ID
- rmc005788ctil
- Conditions
- Unexplained Infertility, Mild Male Factor
- Keywords
- Unexplained infertility, Insemination, Luteal phase support, Ovarian stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 9 Nov 2010 (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 single center, 3 arms, prospective randomized controlled open study to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor.
Patients will be randomized into 3 groups:
- Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)
- Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].
- No luteal support
Detailed description
Study design:
single center, 3 arms, prospective randomized controlled open study
Objective:
to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor.
Methods:
All patients in all study groups will undergo a single insemination procedure and then will be randomized into 3 groups:
- Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)
- Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].
- No luteal support
Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived. A pregnancy test will be performed 2 weeks after insemination (Serum hCG) an intrauterine pregnancy will be confirmed using a transvaginal ultrasound 2 weeks after a positive pregnancy test. If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Luteal support with progesterone only | Experimental | Drug: Luteal support with progesterone onlyLuteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived. |
| Luteal support with estrogen + progesterone | Experimental | Drug: Luteal support with estrogen + progesteroneLuteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg]. |
| No luteal support | No intervention | Procedure: Insemination without luteal support |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Couples with diagnosis of unexplained infertility
- In their treatment cycle with ovarian stimulation and IUI using recombinant FSH in our institution.
Key exclusion criteria (9 listed)
- female partners with one or more of the following:
- sever male factor < 5 million total motile sperm on the day of insemination.
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 |
|---|---|---|
| Luteal support with progesterone onlyLuteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel).Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group. | Drug | Luteal support with progesterone only |
| Luteal support with estrogen + progesteroneLuteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group. | Drug | Luteal support with estrogen + progesterone |
| Insemination without luteal supportRoutine insemination procedure without luteal support | Procedure or surgery | No luteal support |
Primary outcome
Clinical Pregnancy
Time frame: 4 weeks after insemintation
A pregnancy test will be performed 2 weeks after insemination (Serum hCG) an intrauterine pregnancy will be confirmed using a transvaginal ultrasound 2 weeks after a positive pregnancy test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
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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.
Galia Oron, Dr principal investigator
Rabin Medical Center
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 Luteal support with progesterone only, Luteal support with estrogen + progesterone and Insemination without luteal support in people with Unexplained Infertility and Mild Male Factor, run by Rabin Medical Center at 1 site in Israel.
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 9 Nov 2010. 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 Israel. 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 Galia Oron (972-3-9377492, orong@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy (time frame: 4 weeks after insemintation). 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 9 Nov 2010.