InfertilityPhase 4NCT01465373
Vaginal Progesterone Versus Progesterone in Oil in Donor Egg Recipient In Vitro Fertilization Cycles Utilizing Vitrified Donor Eggs
A Phase 4 study testing Endometrin and Progesterone in Oil in people with Infertility, run by Fertility Centers of Illinois at 1 site in United States.
Trial summary
The aim of this study is to evaluate both pharmaceutical therapy and advanced treatment techniques for infertile patients requiring in-vitro fertilization utilizing donor eggs. Read more about this study
- Who is it for?
- Ages 21 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Endometrin and Progesterone in Oil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Sep 2011
- 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 21 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Oocyte Donors:
- Age 21-34 years of age
- BMI 18-34
- Normal ovarian reserve, defined as FSH <10 and AFC >10
- Medical evaluation consistent with FDA criteria for donor inclusion
- Donor Oocyte Recipients
Show all 9Show fewer
- Documented history of infertility requiring donor oocyte for optimal fertility potential
- Documentation of a normal uterine cavity by hysteroscopy, hysterosonogram, or HSG within 1 year of study screening
- Fresh or Frozen Sperm
Who cannot join
- Oocyte Donors:
- Abnormal ovarian reserve, defined as FSH <10, AFC>10, prior poor response to controlled ovarian hyper-stimulation(COHS)
- Failure to meet FDA criteria for donor approval (risk factor and medical evaluation)
- Previous history of poor response to COHS
- Donor Oocyte Recipients:
- Uncontrolled hypothyroidism, hyperprolactinemia, or systemic disease that may interfere with study treatment
Show all 11Show fewer
- Active thrombophlebitis or thromboembolic disorders, or a history of hormone associated thrombophlebitis or thromboembolic disorders
- Surgically aspirated sperm (TESE)
- 2 or more clinical pregnancy losses (excluding aneuploidy for previous autologous cycles)
- Clinically significant gynecologic pathology or uterine abnormality, such as submucosal fibroids > 5 cm, communicating hydrosalpinx, uncorrected uterine septum, undiagnosed vaginal bleeding, endometrial atypia, or any other condition that could adversely affect pregnancy outcomes
- History of 2 or more failed IVF donor cycles
Trial locations and contacts
1 site in 1 country.
United States1 site
Fertility Centers of Illinois
Chicago, Illinois, 60610
About this study
Official title: Comparison of the Effectiveness of Micronized Vaginal Progesterone (Endometrin, Ferring) Vs. Progesterone in Oil for Luteal Phase Support in Donor Egg Recipient IVF Cycles Utilizing Previously Vitrified Donor Oocytes
The aim of this study is to evaluate both pharmaceutical therapy and advanced treatment techniques for infertile patients requiring in-vitro fertilization utilizing donor eggs.
Read the detailed description
The primary objective of this study is to evaluate the clinical pregnancy rate of micronized progesterone (Endometrin, Ferring Pharmaceuticals) compared to progesterone in oil injections in in-vitro fertilization (IVF) donor egg recipients. The secondary objective is to evaluate the effectiveness of freezing/vitrification of donor eggs. Effectiveness of vitrification will be evaluated by egg thaw/survival, fertilization, and implantation rates.
- Conditions
- Infertility
- Being tested
- Endometrin, Progesterone in Oil
- Keywords
- In-Vitro Fertilization, Donor Egg IVF
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndometrinDrug
100 mg per vagina TID
Progesterone in OilDrug
50 mg IM injection daily
| Study group | Role | What they receive |
|---|---|---|
| Progesterone in Oil | Active comparator | Donor egg recipients will begin progesterone 50 mg IM injection starting the day after donor egg fertilization, and continue daily until pregnancy results can be determined.
If pregnant, donor egg recipient will continue progesterone 50 mg IM injections daily until approximately 9 weeks of pregnancy. Receives: Drug: Progesterone in Oil |
| Endometrin | Active comparator | Donor egg recipients will begin Endometrin 100 mg per vagina three times daily starting the day after donor egg fertilization and continue until pregnancy result can be determined.
If pregnant, donor egg recipients will continue Endometrin 100 mg TID until approximately 9 weeks of pregnancy. Receives: Drug: Endometrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate of micronized vaginal progesterone (Endometrin, Ferring Pharmaceuticals) compared to intramuscular progesterone supplementation for luteal phase support after IVF-ET from previously vitrified donor eggs
Measured: 10-12 days post IVF-ET
Secondary outcomes (1)
Evaluation of the effectiveness of vitrification of IVF donor oocytes. Effectiveness will be evaluated by ooctye thaw/survival rates, fertilization and implantation rates assessed from the day of oocyte thawing through IVF cycle outcome.
Measured: six to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startFeb 2010
- Primary completionSep 2011
- Study completionSep 2011
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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fertility Centers of Illinois
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Principal investigator, Sue Jasulaitis, RN MS Clinical Research Coordinator, Fertility Centers of Illinois
- Investigators
- Angeline Beltsos, MD, Principal investigator, Fertility Centers of Illinois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465373
- Sponsor's protocol ID
- 10-019
- Status last verified
- Nov 2011
- First submitted
- 5 May 2010
- Last updated
- 4 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Micronized Vaginal Progesterone (Endometrin, Ferring) Vs. Progesterone in Oil for Luteal Phase Support in Donor Egg Recipient IVF Cycles Utilizing Previously Vitrified Donor Oocytes
- ClinicalTrials.gov ID
- NCT01465373
- Acronym / sponsor ID
- 10-019
- Conditions
- Infertility
- Keywords
- In-Vitro Fertilization, Donor Egg IVF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fertility Centers of IllinoisUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Feb 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Nov 2011 (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.
The aim of this study is to evaluate both pharmaceutical therapy and advanced treatment techniques for infertile patients requiring in-vitro fertilization utilizing donor eggs.
Detailed description
The primary objective of this study is to evaluate the clinical pregnancy rate of micronized progesterone (Endometrin, Ferring Pharmaceuticals) compared to progesterone in oil injections in in-vitro fertilization (IVF) donor egg recipients. The secondary objective is to evaluate the effectiveness of freezing/vitrification of donor eggs. Effectiveness of vitrification will be evaluated by egg thaw/survival, fertilization, and implantation rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone in Oil | Active comparator | Drug: Progesterone in OilDonor egg recipients will begin progesterone 50 mg IM injection starting the day after donor egg fertilization, and continue daily until pregnancy results can be determined. If pregnant, donor egg recipient will continue progesterone 50 mg IM injections daily until approximately 9 weeks of pregnancy. |
| Endometrin | Active comparator | Drug: EndometrinDonor egg recipients will begin Endometrin 100 mg per vagina three times daily starting the day after donor egg fertilization and continue until pregnancy result can be determined. If pregnant, donor egg recipients will continue Endometrin 100 mg TID until approximately 9 weeks of pregnancy. |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 21-34 years of age
- BMI 18-34
- Normal ovarian reserve, defined as FSH <10 and AFC >10
- Medical evaluation consistent with FDA criteria for donor inclusion
- Donor Oocyte Recipients
Key exclusion criteria (11 listed)
- Abnormal ovarian reserve, defined as FSH <10, AFC>10, prior poor response to controlled ovarian hyper-stimulation(COHS)
- Failure to meet FDA criteria for donor approval (risk factor and medical evaluation)
- Previous history of poor response to COHS
- Uncontrolled hypothyroidism, hyperprolactinemia, or systemic disease that may interfere with study treatment
- Active thrombophlebitis or thromboembolic disorders, or a history of hormone associated thrombophlebitis or thromboembolic disorders
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 |
|---|---|---|
| Endometrin100 mg per vagina TID | Drug | Endometrin |
| Progesterone in Oil50 mg IM injection daily | Drug | Progesterone in Oil |
Primary outcome
Clinical pregnancy rate of micronized vaginal progesterone (Endometrin, Ferring Pharmaceuticals) compared to intramuscular progesterone supplementation for luteal phase support after IVF-ET from previously vitrified donor eggs
Time frame: 10-12 days post IVF-ET
1 secondary outcome
Evaluation of the effectiveness of vitrification of IVF donor oocytes. Effectiveness will be evaluated by ooctye thaw/survival rates, fertilization and implantation rates assessed from the day of oocyte thawing through IVF cycle outcome.
Time frame: six to eight weeks
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 4 Nov 2011.
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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.
Angeline Beltsos, MD principal investigator
Fertility Centers of Illinois
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 Endometrin and Progesterone in Oil in people with Infertility, run by Fertility Centers of Illinois 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 9 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: finished, as of the sponsor's last update on 4 Nov 2011. 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 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?
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?
Clinical pregnancy rate of micronized vaginal progesterone (Endometrin, Ferring Pharmaceuticals) compared to intramuscular progesterone supplementation for luteal phase support after IVF-ET from previously vitrified donor eggs (time frame: 10-12 days post IVF-ET). 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 4 Nov 2011.