PregnancyPhase 1NCT02510534
Effect of Luteal Progesterone Support on Pregnancy Rates With Combined Clomid/ Gonadotropin & IUI
A Phase 1 study testing Menopur 150 international units and Endometrin 100 mg in people with Pregnancy, run by Northwest Center for Infertility and Reproductive Endocrinology at 1 site in United States.
Trial summary
To determine the difference in clinical pregnancy rates with and without luteal progesterone support in a young reproductive aged population having undergone ovulation induction with combined clomiphene citrate and gonadotropin protocol with intrauterine insemination. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Menopur 150 international units and Endometrin 100 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Apr 2016
- Phase
- Phase 1
- 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 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-37
- BMI 19-34 kg/m2
- Day 2-3 Follicle stimulating hormone (FSH) less than 10IU/mL
- Estradiol (E2) less than 80 pg/mL
- Anti-mullerian hormone (AMH) more than 1.5 ng/mL; or antral follicle count (AFC) up to 10
- Two patent fallopian tubes confirmed by hysterosalpingogram (HSG) or chromopertubation
- Normal uterine cavity confirmed by HSG, saline sonohysterogram (SIS) or hysteroscopy
Who cannot join
- Severe male factor (total count less than 10 million sperm)
- Systemic diseases not limited to diabetes
- Pregnancy within 3 months
- More than 1 prior cycle of gonadotropin treatment
- Any ovarian cyst >15mm that has persisted for > 1 month
- Endometrioma and/or Endometriosis-stage III or IV
Show all 11Show fewer
- Submucosal uterine fibroids; untreated endometrial polyps >1 cm;abnormal reproductive tract bleeding
- Intolerance or allergy to study drug
- Substance abuse (including alcohol and tobacco)
- History of chemotherapy (except for gestational conditions) or radiotherapy
- Minors and those adults not capable of consenting on their own
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Trial to Study the Effect of Luteal Progesterone Support on Pregnancy Rates in Combined Clomiphene Citrate and Gonadotropin Ovulation Induction Protocol With Intrauterine Insemination.
To determine the difference in clinical pregnancy rates with and without luteal progesterone support in a young reproductive aged population having undergone ovulation induction with combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.
Read the detailed description
To determine the difference in clinical pregnancy rates with and without luteal progesterone support in a young reproductive aged population having undergone ovulation induction with combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.
Patients will be randomized in a treatment arm or control arm. The treatment arm receives the luteal progesterone support and the control arm does not. Each arm will have 260 patients.
- Conditions
- Pregnancy
- Being tested
- Menopur 150 international units, Endometrin 100 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menopur 150 international unitsDrug
Also called Gonadotropin
Menopur 150 international units given x 1 dose
Endometrin 100 mgDrug
Also called Progesterone
Endometrin 100mg twice daily x 14 days
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | This arm receives Menopur 150 international units x 1 dose Receives: Drug: Menopur 150 international units |
| Treatment | Active comparator | This arm receives Menopur 150 international units x 1 dose and Endometrin 100mg twice a day x 14 days Receives: Drug: Menopur 150 international units; Drug: Endometrin 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on Pregnancy rate measured by detectable embryonic cardiac activity
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: unable to enroll participants who meet the criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwest Center for Infertility and Reproductive Endocrinology
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Daniel Christie, MD, Principal investigator, IVF FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510534
- Sponsor's protocol ID
- IVFFL001v2
- Status last verified
- Sep 2016
- First submitted
- 24 Jul 2015
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial to Study the Effect of Luteal Progesterone Support on Pregnancy Rates in Combined Clomiphene Citrate and Gonadotropin Ovulation Induction Protocol With Intrauterine Insemination.
- ClinicalTrials.gov ID
- NCT02510534
- Acronym / sponsor ID
- IVFFL001v2
- Conditions
- Pregnancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to enroll participants who meet the criteria
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Northwest Center for Infertility and Reproductive EndocrinologyUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Jul 2015 (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.
To determine the difference in clinical pregnancy rates with and without luteal progesterone support in a young reproductive aged population having undergone ovulation induction with combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.
Detailed description
To determine the difference in clinical pregnancy rates with and without luteal progesterone support in a young reproductive aged population having undergone ovulation induction with combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.
Patients will be randomized in a treatment arm or control arm. The treatment arm receives the luteal progesterone support and the control arm does not. Each arm will have 260 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Menopur 150 international unitsThis arm receives Menopur 150 international units x 1 dose |
| Treatment | Active comparator | Drug: Menopur 150 international units, Drug: Endometrin 100 mgThis arm receives Menopur 150 international units x 1 dose and Endometrin 100mg twice a day x 14 days |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-37
- BMI 19-34 kg/m2
- Day 2-3 Follicle stimulating hormone (FSH) less than 10IU/mL
- Estradiol (E2) less than 80 pg/mL
- Anti-mullerian hormone (AMH) more than 1.5 ng/mL; or antral follicle count (AFC) up to 10
Key exclusion criteria (11 listed)
- Severe male factor (total count less than 10 million sperm)
- Systemic diseases not limited to diabetes
- Pregnancy within 3 months
- More than 1 prior cycle of gonadotropin treatment
- Any ovarian cyst >15mm that has persisted for > 1 month
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 |
|---|---|---|
| Menopur 150 international unitsAlso: GonadotropinMenopur 150 international units given x 1 dose | Drug | Control, Treatment |
| Endometrin 100 mgAlso: ProgesteroneEndometrin 100mg twice daily x 14 days | Drug | Treatment |
Primary outcome
Effect on Pregnancy rate measured by detectable embryonic cardiac activity
Time frame: 10 months
Results and safety
The study was stopped early (reason given: unable to enroll participants who meet the criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
Daniel Christie, MD principal investigator
IVF FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Menopur 150 international units and Endometrin 100 mg in people with Pregnancy, run by Northwest Center for Infertility and Reproductive Endocrinology at 1 site in United States.
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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 23 Sep 2016. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: unable to enroll participants who meet the criteria). Results are not available in the source record.
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?
Effect on Pregnancy rate measured by detectable embryonic cardiac activity (time frame: 10 months). 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 23 Sep 2016.