InfertilityPhase 4NCT02772120
Comparison of Vaginal and Intramuscular Progesterone in Vitrified-warmed Blastocyst Transfer Cycles
A Phase 4 study testing Vaginal progesterone gel (Crinone® 8%) and Intramuscular Progesterone in people with Infertility, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aim of this study is to test the hypothesis that the pregnancy rates of women (ages 18-50 years) undergoing transfer of vitrified-warmed blastocysts (frozen at less than 41 years of age) as part of their IVF treatment are not different with respect to the administration of progesterone (Crinone® 8% vaginal gel… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Vaginal progesterone gel (Crinone® 8%) and Intramuscular Progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Sep 2019
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent
- Patient age at time of embryo freezing: 18 to 40.9 years
- Patient age at embryo transfer: 18 to 50 years (i.e. women currently ages 18-50 years who are transferring embryos created using eggs retrieved from women aged 18-40.9 years)
- Blastocysts frozen by vitrification at Brigham and Women's Hospital
- Standard eligibility criteria for blastocyst transfer at Brigham and Women's Hospital
Who cannot join
- Fresh or cleavage-stage embryo transfer planned
- Gestational carrier cycles
- Natural and modified natural cycles
- Embryos frozen more than once or derived from thawed oocytes
- Embryos frozen at centers other than Brigham and Women's Hospital
- Embryos frozen using techniques other than vitrification (i.e. slow frozen)
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- Patients with recurrent pregnancy loss, defined as failure of 3 or more clinical pregnancies
- Uterine factor infertility: Asherman's, submucosal fibroids, polyp greater than 1 cm at time of embryo transfer, uninterrupted hydrosalpinx
- Patients with three prior failed embryo transfers (fresh or frozen)
- BMI<18 or >40 kg/m2 at screening
- Currently breast feeding or pregnant
- Embryo biopsy performed
- Current smoking, alcohol or illicit drug use
- Allergy to study drugs
- Refusal or inability to adhere to study protocol
- Participation in other experimental drug trials concurrently within the past 60 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Comparison of Vaginal Progesterone Gel (Crinone 8%®) and Intramuscular Progesterone in Vitrified-Warmed Blastocyst Transfer Cycles
The aim of this study is to test the hypothesis that the pregnancy rates of women (ages 18-50 years) undergoing transfer of vitrified-warmed blastocysts (frozen at less than 41 years of age) as part of their IVF treatment are not different with respect to the administration of progesterone (Crinone® 8% vaginal gel versus intramuscular progesterone).
Read the detailed description
The hypothesis of this study is that the type of progesterone administered (intramuscular progesterone or Crinone® 8% vaginal gel) does not affect implantation and clinical pregnancy rates in women receiving cryo-thawed blastocysts that were produced using their own eggs and frozen before age 41 years. Both intramuscular progesterone (25-100 mg compounded in oil) or vaginal progesterone (Crinone® 8% vaginal progesterone gel) are widely used for luteal phase support in patients receiving vitrified-warmed embryos. Crinone® 8% is FDA approved for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency (FDA approval letter, 1997).
- Conditions
- Infertility
- Being tested
- Vaginal progesterone gel (Crinone® 8%), Intramuscular Progesterone
- Keywords
- Infertility, In vitro fertilization, Embryo transfer, Blastocyst, Progesterone, Crinone
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal progesterone gel (Crinone® 8%)Drug
Also called vaginal progesterone, Crinone
Crinone® 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) is administered once 5 days prior to embryo transfer, then twice per day until the pregnancy test is negative or until the 10th week of pregnancy.
Intramuscular ProgesteroneDrug
Also called progesterone
Progesterone-25 mg intramuscularly once 5 days prior to embryo transfer, then 50 mg once per day until the pregnancy test is negative or until the 10th week of pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal progesterone gel (Crinone® 8%) | Active comparator | Crinone® 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) is administered once 5 days prior to embryo transfer, then twice per day until the pregnancy test is negative or until the 10th week of pregnancy. Receives: Drug: Vaginal progesterone gel (Crinone® 8%) |
| Intramuscular Progesterone | Active comparator | Progesterone-25 mg intramuscularly once 5 days prior to embryo transfer, then 50 mg once per day until the pregnancy test is negative or until the 10th week of pregnancy. Receives: Drug: Intramuscular Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Percentage of patients with intrauterine gestational sac by ultrasound
Measured: 5-6 weeks
Secondary outcomes (4)
Implantation rate
Maximum number of gestational sacs divided by total number of embryos transferred
Measured: 5-6 weeks
Sustained implantation rate
maximum number of fetal heartbeats divided by total number of embryos transferred
Measured: 7 weeks
Biochemical pregnancy
Positive serum b-hCG (above 5 IU/L) without subsequent ultrasound evidence of pregnancy
Measured: 6 weeks
Ongoing pregnancy rate
Live intrauterine pregnancy at the time of transfer to obstetrical care
Measured: 7-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Primary completionSep 2019 (estimated)
Why it stopped: Before enrollment, suspended due to changing insurance coverage of study drugs.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Hesina Yanushpolsky, MD, Brigham and Women's Hospital
- Investigators
- Elena Yanushpolsky, MD, Principal investigator, Assistant Professor, Harvard Medical School, Director of Reproductive Surgery at Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772120
- Sponsor's protocol ID
- BWH2016progRCT
- Status last verified
- Sep 2019
- First submitted
- 11 May 2016
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wang Y, He Y, Zhao X, Ji X, Hong Y, Wang Y, Zhu Q, Xu B, Sun Y. Crinone Gel for Luteal Phase Support in Frozen-Thawed Embryo Transfer Cycles: A Prospective Randomized Clinical Trial in the Chinese Population. PLoS One. 2015 Jul 29;10(7):e0133027. doi: 10.1371/journal.pone.0133027. eCollection 2015.
PubMed 26222435Lightman A, Kol S, Itskovitz-Eldor J. A prospective randomized study comparing intramuscular with intravaginal natural progesterone in programmed thaw cycles. Hum Reprod. 1999 Oct;14(10):2596-9. doi: 10.1093/humrep/14.10.2596.
PubMed 10527993Shapiro DB, Pappadakis JA, Ellsworth NM, Hait HI, Nagy ZP. Progesterone replacement with vaginal gel versus i.m. injection: cycle and pregnancy outcomes in IVF patients receiving vitrified blastocysts. Hum Reprod. 2014 Aug;29(8):1706-11. doi: 10.1093/humrep/deu121. Epub 2014 May 20.
PubMed 24847018Berger BM, Phillips JA. Pregnancy outcomes in oocyte donation recipients: vaginal gel versus intramuscular injection progesterone replacement. J Assist Reprod Genet. 2012 Mar;29(3):237-42. doi: 10.1007/s10815-011-9691-9. Epub 2012 Feb 4.
PubMed 22310935
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vaginal Progesterone Gel (Crinone 8%®) and Intramuscular Progesterone in Vitrified-Warmed Blastocyst Transfer Cycles
- ClinicalTrials.gov ID
- NCT02772120
- Acronym / sponsor ID
- BWH2016progRCT
- Conditions
- Infertility
- Keywords
- Infertility, In vitro fertilization, Embryo transfer, Blastocyst, Progesterone, Crinone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Before enrollment, suspended due to changing insurance coverage of study drugs.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Primary completion
- Sep 2019 (estimated)
- First posted
- 13 May 2016 (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 test the hypothesis that the pregnancy rates of women (ages 18-50 years) undergoing transfer of vitrified-warmed blastocysts (frozen at less than 41 years of age) as part of their IVF treatment are not different with respect to the administration of progesterone (Crinone® 8% vaginal gel versus intramuscular progesterone).
Detailed description
The hypothesis of this study is that the type of progesterone administered (intramuscular progesterone or Crinone® 8% vaginal gel) does not affect implantation and clinical pregnancy rates in women receiving cryo-thawed blastocysts that were produced using their own eggs and frozen before age 41 years. Both intramuscular progesterone (25-100 mg compounded in oil) or vaginal progesterone (Crinone® 8% vaginal progesterone gel) are widely used for luteal phase support in patients receiving vitrified-warmed embryos. Crinone® 8% is FDA approved for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency (FDA approval letter, 1997).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal progesterone gel (Crinone® 8%) | Active comparator | Drug: Vaginal progesterone gel (Crinone® 8%)Crinone® 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) is administered once 5 days prior to embryo transfer, then twice per day until the pregnancy test is negative or until the 10th week of pregnancy. |
| Intramuscular Progesterone | Active comparator | Drug: Intramuscular ProgesteroneProgesterone-25 mg intramuscularly once 5 days prior to embryo transfer, then 50 mg once per day until the pregnancy test is negative or until the 10th week of pregnancy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Patient age at time of embryo freezing: 18 to 40.9 years
- Patient age at embryo transfer: 18 to 50 years (i.e. women currently ages 18-50 years who are transferring embryos created using eggs retrieved from women aged 18-40.9 years)
- Blastocysts frozen by vitrification at Brigham and Women's Hospital
- Standard eligibility criteria for blastocyst transfer at Brigham and Women's Hospital
Key exclusion criteria (16 listed)
- Fresh or cleavage-stage embryo transfer planned
- Gestational carrier cycles
- Natural and modified natural cycles
- Embryos frozen more than once or derived from thawed oocytes
- Embryos frozen at centers other than Brigham and Women's Hospital
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 |
|---|---|---|
| Vaginal progesterone gel (Crinone® 8%)Also: vaginal progesterone, CrinoneCrinone® 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) is administered once 5 days prior to embryo transfer, then twice per day until the pregnancy test is negative or until the 10th week of pregnancy. | Drug | Vaginal progesterone gel (Crinone® 8%) |
| Intramuscular ProgesteroneAlso: progesteroneProgesterone-25 mg intramuscularly once 5 days prior to embryo transfer, then 50 mg once per day until the pregnancy test is negative or until the 10th week of pregnancy. | Drug | Intramuscular Progesterone |
Primary outcome
Clinical pregnancy rate
Time frame: 5-6 weeks
Percentage of patients with intrauterine gestational sac by ultrasound
4 secondary outcomes
Implantation rate
Time frame: 5-6 weeks
Sustained implantation rate
Time frame: 7 weeks
Biochemical pregnancy
Time frame: 6 weeks
Ongoing pregnancy rate
Time frame: 7-8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Background: PubMed 26222435Wang Y, He Y, Zhao X, Ji X, Hong Y, Wang Y, Zhu Q, Xu B, Sun Y. Crinone Gel for Luteal Phase Support in Frozen-Thawed Embryo Transfer Cycles: A Prospective Randomized Clinical Trial in the Chinese Population. PLoS One. 2015 Jul 29;10(7):e0133027. doi: 10.1371/journal.pone.0133027. eCollection 2015.
- Background: PubMed 10527993Lightman A, Kol S, Itskovitz-Eldor J. A prospective randomized study comparing intramuscular with intravaginal natural progesterone in programmed thaw cycles. Hum Reprod. 1999 Oct;14(10):2596-9. doi: 10.1093/humrep/14.10.2596.
- Background: PubMed 24847018Shapiro DB, Pappadakis JA, Ellsworth NM, Hait HI, Nagy ZP. Progesterone replacement with vaginal gel versus i.m. injection: cycle and pregnancy outcomes in IVF patients receiving vitrified blastocysts. Hum Reprod. 2014 Aug;29(8):1706-11. doi: 10.1093/humrep/deu121. Epub 2014 May 20.
- Background: PubMed 22310935Berger BM, Phillips JA. Pregnancy outcomes in oocyte donation recipients: vaginal gel versus intramuscular injection progesterone replacement. J Assist Reprod Genet. 2012 Mar;29(3):237-42. doi: 10.1007/s10815-011-9691-9. Epub 2012 Feb 4.
- Drug information for progesteroneLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Elena Yanushpolsky, MD principal investigator
Assistant Professor, Harvard Medical School, Director of Reproductive Surgery at Brigham and Women's Hospital
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 Vaginal progesterone gel (Crinone® 8%) and Intramuscular Progesterone in people with Infertility, run by Brigham and Women's Hospital 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 5 inclusion and 16 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: withdrawn, as of the sponsor's last update on 9 Sep 2019. 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 was withdrawn before enrolling participants, so there are no results.
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 (time frame: 5-6 weeks). 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 NCT02772120, which also lists 4 linked publications.
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 Sep 2019.