Reproductive Techniques, AssistedLUTEALNCT02625532
Early Follicular Phase vs Lutheal Phase Ovarian Stimulation in Bologna Criteria IVF/ICSI Cycles (LUTEAL Trial)
A study testing Follicular phase and Luteal phase in people with Reproductive Techniques, Assisted, run by Instituto Bernabeu at 1 site in Spain.
Trial summary
Exploratory, prospective, randomized, comparative, open trial with control group treated to assess the efficacy of follicular phase ovarian stimulation compared to lutheal phase ovarian stimulation in women with Bologna criteria for poor ovarian response. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive Techniques, Assisted
- What is being tested?
- Follicular phase and Luteal phase
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2015to Jan 2019
- Phase
- Interventional
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient Bologna meets the criteria to be diagnosed as low responder
- Age under 41 years
- Regular menstrual cycles between 21 and 35 days
- Indication of in vitro fertilization
- Indication of start stimulation with 300 IU of FSH
- Presence of both ovaries
- Ability to participate and comply with the study protocol
- Having signed the written consent form
Who cannot join
- Presence of follicles larger than 10 mm in the randomization visit
- Endometriosis III / IV
- Concomitant uterine pathology: adenomyosis, submucosal myomas, Asherman's syndrome...
- Concurrent participation in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Follicular Phase vs Lutheal Phase Ovarian Stimulation in Bologna Criteria IVF/ICSI Cycles: A Randomized Comparative Single Center Trial. LUTEAL Trial
Exploratory, prospective, randomized, comparative, open trial with control group treated to assess the efficacy of follicular phase ovarian stimulation compared to lutheal phase ovarian stimulation in women with Bologna criteria for poor ovarian response.
Read the detailed description
Two arms is established, the study group that will start ovarian stimulation in the luteal phase and the control group that will start ovarian stimulation in the follicular phase.
The randomization will be made in the 2-3 day of the menstrual cycle, according to a list of random allocation of treatments. After check that there is no contraindication to start the stimulation, the patients will be assigned to the treatment group.
The patients in the control group (follicular phase group) will start stimulation with two vials of 150 IU recombinant FSH + 75 IU recombinant LH (Pergoveris® 150/75). The patients in the study group (luteal phase group) will perform daily urine LH test from day 7th of the cycle and will start the administration of 150 IU recombinant FSH + 75 IU recombinant LH (Pergoveris® 150/75) at two vials daily from the 4th day of the LH positive test.
Antagonist cetrorelix acetate (Cetrotide® ) administration will start when the largest follicle shall be equal or greater than 14 mm. From this moment controls every 24-72 hours with foliculometría by ultrasound and blood hormone analysis with determination of estradiol and progesterone. For the final oocyte maturation 2 vials daily of 0.2 mg triptorelin acetate (Decapeptyl®) is administered. Oocyte collection will be made by transvaginal ultrasound-guided puncture according to IB protocol
The dosages and protocols used will be the usual for patients with diagnostic of poor ovarian response.
- Conditions
- Reproductive Techniques, Assisted
- Being tested
- Follicular phase, Luteal phase
- Keywords
- Controlled Ovarian stimulation, Follicular phase, Luteal phase, Reproductive Techniques, Assisted
- Medical subject headings
- Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follicular phaseProcedure or surgery
Also called Ovarian stimulation starts during the follicular phase
Controlled ovarian stimulation starts on day 2-3 of the menstrual cycle with recombinant recombinant FSH + LH, adding cetrorelix when the follicles reach 14 mm size and ovarian maturation with triptorelin acetate
Luteal phaseProcedure or surgery
Also called Ovarian stimulation starts during the luteal phase
Controlled ovarian stimulation is started between 3rd and 5th day after the first LH positive urine test, adding cetrorelix when follicles reached 14 mm size and ovarian maturation with triptorelin acetate
| Study group | Role | What they receive |
|---|---|---|
| Follicular phase | Active comparator | Controlled ovarian stimulation starts during follicular phase on day 2-3 of the menstrual cycle Receives: Procedure: Follicular phase |
| Luteal phase | Experimental | Controlled ovarian stimulation starts during luteal phase on day 3 to 5 after first LH positive urine test Receives: Procedure: Luteal phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of oocytes in metaphase II obtained
number of oocytes in metaphase II obtained by follicular puncture
Measured: Through study completion, average 2 weeks
Secondary outcomes (6)
number of oocytes cumulus complexes
number of oocytes cumulus complexes obtained by follicular puncture
Measured: Through study completion, average 2 weeks
duration of stimulation (days)
number of days from the start of ovarian stimulation until the day of follicular puncture
Measured: Through study completion, average 2 weeks
cycle cancellation rate
ratio of canceled cycles regarding the number of ovarian stimulation cycles initiated
Measured: Through study completion, average 2 weeks
Luteinizing hormone levels following administration of agonist for final oocyte maturation
Luteinizing hormone blood levels the day after administration of agonist for final oocyte maturation
Measured: Through study completion, average 2 weeks
occurrence of side effects
occurrence of side effects at the end of study
Measured: Through study completion, average 2 weeks
fertilization rate
Number of correct fertilization oocytes 18 hours post-insemination
Measured: Through study completion, average 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionOct 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reproductive Techniques, AssistedStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Bernabeu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquín Llácer, Instituto Bernabeu
- Investigators
- Joaquín Llácer, Principal investigator, Instituto Bernabeu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625532
- Sponsor's protocol ID
- BER-LUT-2015-02
- Other IDs
- 2015-003856-31, 2015
- Acronym
- LUTEAL
- Status last verified
- Aug 2018
- First submitted
- 9 Nov 2015
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Llacer J, Moliner B, Luque L, Bernabeu A, Lledo B, Castillo JC, Guerrero J, Ten J, Bernabeu R. Luteal phase stimulation versus follicular phase stimulation in poor ovarian responders: results of a randomized controlled trial. Reprod Biol Endocrinol. 2020 Feb 7;18(1):9. doi: 10.1186/s12958-020-00570-7.
PubMed 32033610
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Follicular Phase vs Lutheal Phase Ovarian Stimulation in Bologna Criteria IVF/ICSI Cycles: A Randomized Comparative Single Center Trial. LUTEAL Trial
- ClinicalTrials.gov ID
- NCT02625532
- Acronym / sponsor ID
- LUTEAL / BER-LUT-2015-02
- Conditions
- Reproductive Techniques, Assisted
- Keywords
- Controlled Ovarian stimulation, Follicular phase, Luteal phase, Reproductive Techniques, Assisted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto BernabeuUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 9 Dec 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.
Exploratory, prospective, randomized, comparative, open trial with control group treated to assess the efficacy of follicular phase ovarian stimulation compared to lutheal phase ovarian stimulation in women with Bologna criteria for poor ovarian response.
Detailed description
Two arms is established, the study group that will start ovarian stimulation in the luteal phase and the control group that will start ovarian stimulation in the follicular phase.
The randomization will be made in the 2-3 day of the menstrual cycle, according to a list of random allocation of treatments. After check that there is no contraindication to start the stimulation, the patients will be assigned to the treatment group.
The patients in the control group (follicular phase group) will start stimulation with two vials of 150 IU recombinant FSH + 75 IU recombinant LH (Pergoveris® 150/75). The patients in the study group (luteal phase group) will perform daily urine LH test from day 7th of the cycle and will start the administration of 150 IU recombinant FSH + 75 IU recombinant LH (Pergoveris® 150/75) at two vials daily from the 4th day of the LH positive test.
Antagonist cetrorelix acetate (Cetrotide® ) administration will start when the largest follicle shall be equal or greater than 14 mm. From this moment controls every 24-72 hours with foliculometría by ultrasound and blood hormone analysis with determination of estradiol and progesterone. For the final oocyte maturation 2 vials daily of 0.2 mg triptorelin acetate (Decapeptyl®) is administered. Oocyte collection will be made by transvaginal ultrasound-guided puncture according to IB protocol
The dosages and protocols used will be the usual for patients with diagnostic of poor ovarian response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follicular phase | Active comparator | Procedure: Follicular phaseControlled ovarian stimulation starts during follicular phase on day 2-3 of the menstrual cycle |
| Luteal phase | Experimental | Procedure: Luteal phaseControlled ovarian stimulation starts during luteal phase on day 3 to 5 after first LH positive urine test |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patient Bologna meets the criteria to be diagnosed as low responder
- Age under 41 years
- Regular menstrual cycles between 21 and 35 days
- Indication of in vitro fertilization
- Indication of start stimulation with 300 IU of FSH
Key exclusion criteria (4 listed)
- Presence of follicles larger than 10 mm in the randomization visit
- Endometriosis III / IV
- Concomitant uterine pathology: adenomyosis, submucosal myomas, Asherman's syndrome...
- Concurrent participation in another study
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 |
|---|---|---|
| Follicular phaseAlso: Ovarian stimulation starts during the follicular phaseControlled ovarian stimulation starts on day 2-3 of the menstrual cycle with recombinant recombinant FSH + LH, adding cetrorelix when the follicles reach 14 mm size and ovarian maturation with triptorelin acetate | Procedure or surgery | Follicular phase |
| Luteal phaseAlso: Ovarian stimulation starts during the luteal phaseControlled ovarian stimulation is started between 3rd and 5th day after the first LH positive urine test, adding cetrorelix when follicles reached 14 mm size and ovarian maturation with triptorelin acetate | Procedure or surgery | Luteal phase |
Primary outcome
number of oocytes in metaphase II obtained
Time frame: Through study completion, average 2 weeks
number of oocytes in metaphase II obtained by follicular puncture
6 secondary outcomes
number of oocytes cumulus complexes
Time frame: Through study completion, average 2 weeks
duration of stimulation (days)
Time frame: Through study completion, average 2 weeks
cycle cancellation rate
Time frame: Through study completion, average 2 weeks
Luteinizing hormone levels following administration of agonist for final oocyte maturation
Time frame: Through study completion, average 2 weeks
occurrence of side effects
Time frame: Through study completion, average 2 weeks
fertilization rate
Time frame: Through study completion, average 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Derived from this study: PubMed 32033610Llacer J, Moliner B, Luque L, Bernabeu A, Lledo B, Castillo JC, Guerrero J, Ten J, Bernabeu R. Luteal phase stimulation versus follicular phase stimulation in poor ovarian responders: results of a randomized controlled trial. Reprod Biol Endocrinol. 2020 Feb 7;18(1):9. doi: 10.1186/s12958-020-00570-7.
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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.
Joaquín Llácer 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 study testing Follicular phase and Luteal phase in people with Reproductive Techniques, Assisted, 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 8 inclusion and 4 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 29 Aug 2018. 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.
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?
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?
number of oocytes in metaphase II obtained (time frame: Through study completion, average 2 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 NCT02625532, which also lists 1 linked publication.
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 29 Aug 2018.