InfertilityPhase 4NCT02363127
Subcutaneous Progesterone Versus Vaginal Progesterone for Endometrial Preparation in Fresh Donated Oocytes Recipients
A Phase 4 study testing subcutaneous progesterone and vaginal progesterone in people with Infertility, run by Instituto Bernabeu at 1 site in Spain.
Trial summary
Randomised, prospective, investigator-blinded, controlled, single-centre study to assess the impact on the ongoing pregnancy rate with the use of two progesterones with different administration routes, in recipients of fresh embryos from donor oocytes, undergoing endometrial preparation for fresh embryo transfer. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- subcutaneous progesterone and vaginal progesterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2015to Dec 2016
- 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 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, aged from 18 to 49 years (both inclusive)
- Woman who wishes to become pregnant
- Endometrial thickness greater 7 mm on the day of patient randomisation to one of the progesterone groups
- Six or more donor retrieved oocytes
- Patient programmed for fresh embryo transfer on day +5 of embryo culture
- BMI lower than 30 Kg/m2
Show all 12Show fewer
- Infertility that justifies treatment with donor oocytes
- Male with no known karyotype alterations
- Semen by ejaculation from either the partner or from a bank
- Uterus able to support embryo implantation and pregnancy
- Absence of pregnancy before starting the embryo transfer cycle
- Has given prior written consent
Who cannot join
- - Important systemic diseases, endocrine-metabolic abnormalities involving the pituitary, thyroid, adrenals, pancreas, liver or kidney.
- HIV, HBV or HCV seropositivity
- Undiagnosed vaginal bleeding
- Pregnancy, breastfeeding or any contraindication to becoming pregnant
- Malformation of sexual organs incompatible with pregnancy
- Known allergy to progesterone preparations or their excipients
Show all 9Show fewer
- Current dependence on alcohol, drugs or psychotropic medication
- Concurrent participation in another study
- Concomitant medication that could interfere with the study medication: different hormonal treatments used in the study, except thyroid hormones, antipsychotics, anxiolytics, hypnotics, sedatives, chronic treatment with prostaglandin inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subcutaneous Progesterone (Prolutex) Versus Vaginal Progesterone Capsules (Progeffik) for Endometrial Preparation in Fresh Donated Oocytes Recipients: a Randomised, Prospective, Single-blind, Pilot Study
Randomised, prospective, investigator-blinded, controlled, single-centre study to assess the impact on the ongoing pregnancy rate with the use of two progesterones with different administration routes, in recipients of fresh embryos from donor oocytes, undergoing endometrial preparation for fresh embryo transfer.
Read the detailed description
Exploratory study with a control group treated according to our Service's usual therapeutic regimen for the transfer of embryos with donor oocytes.
The controlled ovarian stimulation protocol in oocyte donors is always calculated according to the standard protocol at the Bernabeu Institute. Endometrial preparation will be carried out following the standard protocol of the Bernabeu Institute as follows: the oestrogen will be administered transdermally and patients with maintained ovarian function undergo medical hypophysectomy with depot GnRH agonists administered in the mid-luteal phase of the previous cycle.
On the day of oocyte retrieval, the patient will be randomised: Group A will be administered subcutaneous progesterone 25 mg/day (Prolutex), and Group B will be administered vaginal progesterone in capsules 200 mg/3 times a day (Progeffik).
The embryo transfer will be performed on day 5 of the embryo culture (Day +5). A biochemical pregnancy test beta- hCG and the P4 analysis will be performed 14 days after oocyte retrieval.
All the cycles will be monitored according to the Department's standard criteria, using transvaginal ultrasound to assess embryonic development and endometrial thickness, as well as analytical controls.
The study will be blinded to the investigator. The evaluating professionals will not know if the subject has been administered vaginal progesterone or subcutaneous progesterone. The medication will be delivered by a person who does not participate in the evaluations and who is dedicated to group assignment, to data centralisation, and to delivering the medication.
The aim of this study is to determine if the ongoing pregnancy rate in patients undergoing a fresh embryo transfer cycle with donor oocytes is affected by the progesterone administration route.
- Conditions
- Infertility
- Being tested
- subcutaneous progesterone, vaginal progesterone
- Keywords
- Reproductive Techniques, Infertility, Reproductive Techniques Assisted
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous progesteroneDrug
Also called Protulex
subcutaneous progesterone 25 mg/day
vaginal progesteroneDrug
Also called Progeffik
vaginal progesterone in capsules 200 mg/3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Prolutex | Experimental | Subcutaneous progesterone Receives: Drug: subcutaneous progesterone |
| Progeffik | Active comparator | Vaginal progesterone Receives: Drug: vaginal progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
ongoing pregnancy rate at 12 weeks gestation
ongoing pregnancy rate at 12 weeks gestation using subcutaneous progesterone and using vaginal progesterone capsules
Measured: 12 weeks
Secondary outcomes (12)
progesterone level on the days of the transfer
progesterone level on the days of the transfer
Measured: 5 days
progesterone level on biochemical pregnancy test beta-hCG
progesterone level on biochemical pregnancy test beta-hCG
Measured: 14 days
endometrium thickness on the day of oocyte retrieval
endometrium thickness on the day of oocyte retrieval
Measured: 0 day
endometrium thickness on the day of embryo transfer
endometrium thickness on the day of embryo transfer
Measured: 5 days
endometrium morphology on the day of oocyte retrieval
endometrium morphology (trilaminar pattern and echogenicity) on the day of oocyte retrieval
Measured: 0 day
endometrium morphology on the day of embryo transfer
endometrium morphology (trilaminar pattern and echogenicity) on the day of embryo transfer
Measured: 5 days
implantation rate
number of embryo sacs at 4-5 weeks (by ultrasound) versus number of embryos transferred
Measured: 4-5 weeks
positive biochemical pregnancy test beta- hCG rate
positive biochemical pregnancy test beta- hCG rate at 14 days
Measured: 14 days
clinical pregnancy rate
rate of patients with embryo any sac with a heartbeat (by ultrasound)
Measured: 4-5 weeks
miscarriage rate
miscarriage rate in patients with positive biochemical pregnancy test beta- hCG rate on day +14
Measured: 10 weeks
occurrence of side effects
occurrence of side effects associated with progesterone
Measured: day 5, day 14, 4-5 days, 10 weeks
comfort in relation to the progesterone administration route
comfort in relation to the progesterone administration route
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2016
- Study completionDec 2016
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Bernabeu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquín Llácer, Instituto Bernabeu
- Investigators
- Joanquin Llacer, Ph, Principal investigator, Instituto Bernabeu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363127
- Sponsor's protocol ID
- BER-PRO-2014-01
- Status last verified
- Aug 2016
- First submitted
- 9 Feb 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Progesterone (Prolutex) Versus Vaginal Progesterone Capsules (Progeffik) for Endometrial Preparation in Fresh Donated Oocytes Recipients: a Randomised, Prospective, Single-blind, Pilot Study
- ClinicalTrials.gov ID
- NCT02363127
- Acronym / sponsor ID
- BER-PRO-2014-01
- Conditions
- Infertility
- Keywords
- Reproductive Techniques, Infertility, Reproductive Techniques Assisted
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Instituto BernabeuUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Feb 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.
Randomised, prospective, investigator-blinded, controlled, single-centre study to assess the impact on the ongoing pregnancy rate with the use of two progesterones with different administration routes, in recipients of fresh embryos from donor oocytes, undergoing endometrial preparation for fresh embryo transfer.
Detailed description
Exploratory study with a control group treated according to our Service's usual therapeutic regimen for the transfer of embryos with donor oocytes.
The controlled ovarian stimulation protocol in oocyte donors is always calculated according to the standard protocol at the Bernabeu Institute. Endometrial preparation will be carried out following the standard protocol of the Bernabeu Institute as follows: the oestrogen will be administered transdermally and patients with maintained ovarian function undergo medical hypophysectomy with depot GnRH agonists administered in the mid-luteal phase of the previous cycle.
On the day of oocyte retrieval, the patient will be randomised: Group A will be administered subcutaneous progesterone 25 mg/day (Prolutex), and Group B will be administered vaginal progesterone in capsules 200 mg/3 times a day (Progeffik).
The embryo transfer will be performed on day 5 of the embryo culture (Day +5). A biochemical pregnancy test beta- hCG and the P4 analysis will be performed 14 days after oocyte retrieval.
All the cycles will be monitored according to the Department's standard criteria, using transvaginal ultrasound to assess embryonic development and endometrial thickness, as well as analytical controls.
The study will be blinded to the investigator. The evaluating professionals will not know if the subject has been administered vaginal progesterone or subcutaneous progesterone. The medication will be delivered by a person who does not participate in the evaluations and who is dedicated to group assignment, to data centralisation, and to delivering the medication.
The aim of this study is to determine if the ongoing pregnancy rate in patients undergoing a fresh embryo transfer cycle with donor oocytes is affected by the progesterone administration route.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolutex | Experimental | Drug: subcutaneous progesteroneSubcutaneous progesterone |
| Progeffik | Active comparator | Drug: vaginal progesteroneVaginal progesterone |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Female, aged from 18 to 49 years (both inclusive)
- Woman who wishes to become pregnant
- Endometrial thickness greater 7 mm on the day of patient randomisation to one of the progesterone groups
- Six or more donor retrieved oocytes
- Patient programmed for fresh embryo transfer on day +5 of embryo culture
Key exclusion criteria (9 listed)
- - Important systemic diseases, endocrine-metabolic abnormalities involving the pituitary, thyroid, adrenals, pancreas, liver or kidney.
- HIV, HBV or HCV seropositivity
- Undiagnosed vaginal bleeding
- Pregnancy, breastfeeding or any contraindication to becoming pregnant
- Malformation of sexual organs incompatible with pregnancy
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 |
|---|---|---|
| subcutaneous progesteroneAlso: Protulexsubcutaneous progesterone 25 mg/day | Drug | Prolutex |
| vaginal progesteroneAlso: Progeffikvaginal progesterone in capsules 200 mg/3 times a day | Drug | Progeffik |
Primary outcome
ongoing pregnancy rate at 12 weeks gestation
Time frame: 12 weeks
ongoing pregnancy rate at 12 weeks gestation using subcutaneous progesterone and using vaginal progesterone capsules
12 secondary outcomes
progesterone level on the days of the transfer
Time frame: 5 days
progesterone level on biochemical pregnancy test beta-hCG
Time frame: 14 days
endometrium thickness on the day of oocyte retrieval
Time frame: 0 day
endometrium thickness on the day of embryo transfer
Time frame: 5 days
endometrium morphology on the day of oocyte retrieval
Time frame: 0 day
endometrium morphology on the day of embryo transfer
Time frame: 5 days
implantation rate
Time frame: 4-5 weeks
positive biochemical pregnancy test beta- hCG rate
Time frame: 14 days
clinical pregnancy rate
Time frame: 4-5 weeks
miscarriage rate
Time frame: 10 weeks
occurrence of side effects
Time frame: day 5, day 14, 4-5 days, 10 weeks
comfort in relation to the progesterone administration route
Time frame: 10 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 3 Mar 2017.
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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.
Joanquin Llacer, Ph principal investigator
Instituto Bernabeu
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 subcutaneous progesterone and vaginal progesterone in people with Infertility, run by Instituto Bernabeu at 1 site in Spain.
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 12 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: finished, as of the sponsor's last update on 3 Mar 2017. 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 Spain. 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?
ongoing pregnancy rate at 12 weeks gestation (time frame: 12 weeks). 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 3 Mar 2017.