InfertilityIAD-P4NCT02447588
IUI Schedule in Cases of High Progesterone
A study testing IAD at 36 hours and IAD at 24 hours in people with Infertility, run by IVI Madrid.
Trial summary
Intrauterine insemination (IUI) combined with ovarian stimulation protocols has become one of the first alternative treatment against infertility, although results in gestational terms are highly variable, ranging between 10% and 25%. 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
- Infertility
- What is being tested?
- IAD at 36 hours and IAD at 24 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Oct 2016
- 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
- Body mass index (BMI) 18-30 kg / m2
- Patent tubes
- Regular cycles (26-35 days)
- FSH levels on day 3 of cycle (<10 mIU / ml)
- Estradiol levels on day 3 of cycle (<60 pg / ml)
- Progesterone levels the day of hCG (> 1 ng / ml)
- Semen donors belonging to the bank of IVI
Who cannot join
- Patients with ≥3 follicles of over 16 mm diameter
- No dominant follicle after two consecutive ultrasound
- Women with P <1 ng / ml on the day of hCG
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Programming IUI With Sperm Donor in Patients With High Progesterone the Day of hCG Administration
Intrauterine insemination (IUI) combined with ovarian stimulation protocols has become one of the first alternative treatment against infertility, although results in gestational terms are highly variable, ranging between 10% and 25%. The influence of progesterone levels in stimulated cycles of intrauterine insemination is an aspect little studied; however, this information may be useful when synchronizing the time of insemination with the implantation window, as it has been observed that patients with elevated levels of progesterone in the follicular phase exhibit a significant decrease in ongoing pregnancy rates, these results being possible due to premature ovulation which causes asynchrony between the embryo and the endometrium.
Taking into account these considerations, the aim of the investigators' study is to determine the effectiveness, in terms of ongoing pregnancy rates, to advance the intrauterine insemination with sperm donor (24 hours post-hCG) with respect to the standard schedule (36 hours post-hCG) according progesterone levels determined the day of hCG administration
Read the detailed description
Correct schedule of intrauterine insemination is essential to the success of these treatments due to the limited range in which the capacitated sperm survive the female genital tract and oocytes can be fertilized after ovulation. For intrauterine insemination, the fraction of motile sperm is injected directly into the uterine cavity and later migrate into abdominal cavity, where they remain a few hours after insemination; meanwhile, fertilizable oocytes are only between 12-16 hours after ovulation. In the cycles in which follicular growth is monitored, a spontaneous LH surge before ovulation induction with HCG is a possibility; indeed, in stimulated cycles LH is not usually determined so clinicians are not able to know if there has been or not ovulation. Ovulation usually occurs 24 hours after the LH surge; therefore, an insemination performed 36 hours after ovulation induction may be too late in cases of premature ovulation.
The influence of progesterone levels in stimulated cycles of intrauterine insemination is an aspect little studied; however, this information can be useful when synchronizing the time of insemination with the implantation window.
The day of ovulation induction, the investigators will determine progesterone levels. If progesterone> 1 ng / ml the patient be randomized in one of the following groups:
- Group 1 (intrauterine insemination with sperm donor IAD at 36 hours post-hCG). Cases where the IAD is scheduled at 36 hours post-administration of hCG.
- Group 2 (IAD at 24 hours post-hCG). Cases where the IAD is scheduled at 24 hours post-administration of hCG.
- Conditions
- Infertility
- Being tested
- IAD at 36 hours, IAD at 24 hours
- Keywords
- intrauterine insemination, progesterone
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IAD at 36 hoursOther
Intrauterine insemination with sperm donor at 36 hours post-hCG
IAD at 24 hoursOther
Intrauterine insemination with sperm donor at 24 hours post-hCG
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Intrauterine insemination with sperm donor (IAD) at 36 hours post-hCG. Cases where the IAD is scheduled at 36 hours post-administration of hCG. Receives: Other: IAD at 36 hours |
| Group 2 | Experimental | Intrauterine insemination with sperm donor (IAD) at 24 hours post-hCG. Cases where the IAD is scheduled at 24 hours post-administration of hCG. Receives: Other: IAD at 24 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Measured: 1 month
Secondary outcomes (7)
Doses of gonadotropins
Measured: 1 day
Estradiol levels the day of hCG administration
Measured: 1 day
LH levels the day of hCG administration
Measured: 1 day
Days of stimulation
Measured: 1 day
Cancellation rate
Measured: 1 month
Pregnancy rate
Measured: 1 month
Miscarriage rate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016 (estimated)
- Study completionOct 2016 (estimated)
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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Vida Recoletas Sevilla, IVI Vigo
- Responsible party
- Principal investigator, Antonio Requena, IVI Madrid
- Investigators
- Antonio Requena, PhD, MD, Principal investigator, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447588
- Sponsor's protocol ID
- 1504-MAD-021-AR
- Acronym
- IAD-P4
- Status last verified
- May 2015
- First submitted
- 7 May 2015
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Venetis CA, Kolibianakis EM, Papanikolaou E, Bontis J, Devroey P, Tarlatzis BC. Is progesterone elevation on the day of human chorionic gonadotrophin administration associated with the probability of pregnancy in in vitro fertilization? A systematic review and meta-analysis. Hum Reprod Update. 2007 Jul-Aug;13(4):343-55. doi: 10.1093/humupd/dmm007. Epub 2007 Apr 3.
PubMed 17405832Antaki R, Dean NL, Lapensee L, Racicot MH, Menard S, Kadoch IJ. An algorithm combining ultrasound monitoring and urinary luteinizing hormone testing: a novel approach for intrauterine insemination timing. J Obstet Gynaecol Can. 2011 Dec;33(12):1248-52. doi: 10.1016/s1701-2163(16)35110-6.
PubMed 22166279Azem F, Tal G, Lessing JB, Malcov M, Ben-Yosef D, Almog B, Amit A. Does high serum progesterone level on the day of human chorionic gonadotropin administration affect pregnancy rate after intracytoplasmic sperm injection and embryo transfer? Gynecol Endocrinol. 2008 Jul;24(7):368-72. doi: 10.1080/09513590802196353.
PubMed 18645708Blockeel C, Knez J, Polyzos NP, De Vos M, Camus M, Tournaye H. Should an intrauterine insemination with donor semen be performed 1 or 2 days after the spontaneous LH rise? A prospective RCT. Hum Reprod. 2014 Apr;29(4):697-703. doi: 10.1093/humrep/deu022. Epub 2014 Feb 18.
PubMed 24549212
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programming IUI With Sperm Donor in Patients With High Progesterone the Day of hCG Administration
- ClinicalTrials.gov ID
- NCT02447588
- Acronym / sponsor ID
- IAD-P4 / 1504-MAD-021-AR
- Conditions
- Infertility
- Keywords
- intrauterine insemination, progesterone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Collaborators
- Vida Recoletas Sevilla, IVI Vigo
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 19 May 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.
Intrauterine insemination (IUI) combined with ovarian stimulation protocols has become one of the first alternative treatment against infertility, although results in gestational terms are highly variable, ranging between 10% and 25%. The influence of progesterone levels in stimulated cycles of intrauterine insemination is an aspect little studied; however, this information may be useful when synchronizing the time of insemination with the implantation window, as it has been observed that patients with elevated levels of progesterone in the follicular phase exhibit a significant decrease in ongoing pregnancy rates, these results being possible due to premature ovulation which causes asynchrony between the embryo and the endometrium.
Taking into account these considerations, the aim of the investigators' study is to determine the effectiveness, in terms of ongoing pregnancy rates, to advance the intrauterine insemination with sperm donor (24 hours post-hCG) with respect to the standard schedule (36 hours post-hCG) according progesterone levels determined the day of hCG administration
Detailed description
Correct schedule of intrauterine insemination is essential to the success of these treatments due to the limited range in which the capacitated sperm survive the female genital tract and oocytes can be fertilized after ovulation. For intrauterine insemination, the fraction of motile sperm is injected directly into the uterine cavity and later migrate into abdominal cavity, where they remain a few hours after insemination; meanwhile, fertilizable oocytes are only between 12-16 hours after ovulation. In the cycles in which follicular growth is monitored, a spontaneous LH surge before ovulation induction with HCG is a possibility; indeed, in stimulated cycles LH is not usually determined so clinicians are not able to know if there has been or not ovulation. Ovulation usually occurs 24 hours after the LH surge; therefore, an insemination performed 36 hours after ovulation induction may be too late in cases of premature ovulation.
The influence of progesterone levels in stimulated cycles of intrauterine insemination is an aspect little studied; however, this information can be useful when synchronizing the time of insemination with the implantation window.
The day of ovulation induction, the investigators will determine progesterone levels. If progesterone> 1 ng / ml the patient be randomized in one of the following groups:
- Group 1 (intrauterine insemination with sperm donor IAD at 36 hours post-hCG). Cases where the IAD is scheduled at 36 hours post-administration of hCG.
- Group 2 (IAD at 24 hours post-hCG). Cases where the IAD is scheduled at 24 hours post-administration of hCG.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Other: IAD at 36 hoursIntrauterine insemination with sperm donor (IAD) at 36 hours post-hCG. Cases where the IAD is scheduled at 36 hours post-administration of hCG. |
| Group 2 | Experimental | Other: IAD at 24 hoursIntrauterine insemination with sperm donor (IAD) at 24 hours post-hCG. Cases where the IAD is scheduled at 24 hours post-administration of hCG. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Body mass index (BMI) 18-30 kg / m2
- Patent tubes
- Regular cycles (26-35 days)
- FSH levels on day 3 of cycle (<10 mIU / ml)
- Estradiol levels on day 3 of cycle (<60 pg / ml)
Key exclusion criteria (3 listed)
- Patients with ≥3 follicles of over 16 mm diameter
- No dominant follicle after two consecutive ultrasound
- Women with P <1 ng / ml on the day of hCG
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 |
|---|---|---|
| IAD at 36 hoursIntrauterine insemination with sperm donor at 36 hours post-hCG | Other | Group 1 |
| IAD at 24 hoursIntrauterine insemination with sperm donor at 24 hours post-hCG | Other | Group 2 |
Primary outcome
Ongoing pregnancy rate
Time frame: 1 month
7 secondary outcomes
Doses of gonadotropins
Time frame: 1 day
Estradiol levels the day of hCG administration
Time frame: 1 day
LH levels the day of hCG administration
Time frame: 1 day
Days of stimulation
Time frame: 1 day
Cancellation rate
Time frame: 1 month
Pregnancy rate
Time frame: 1 month
Miscarriage rate
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
- Background: PubMed 17405832Venetis CA, Kolibianakis EM, Papanikolaou E, Bontis J, Devroey P, Tarlatzis BC. Is progesterone elevation on the day of human chorionic gonadotrophin administration associated with the probability of pregnancy in in vitro fertilization? A systematic review and meta-analysis. Hum Reprod Update. 2007 Jul-Aug;13(4):343-55. doi: 10.1093/humupd/dmm007. Epub 2007 Apr 3.
- Results publication: PubMed 22166279Antaki R, Dean NL, Lapensee L, Racicot MH, Menard S, Kadoch IJ. An algorithm combining ultrasound monitoring and urinary luteinizing hormone testing: a novel approach for intrauterine insemination timing. J Obstet Gynaecol Can. 2011 Dec;33(12):1248-52. doi: 10.1016/s1701-2163(16)35110-6.
- Results publication: PubMed 18645708Azem F, Tal G, Lessing JB, Malcov M, Ben-Yosef D, Almog B, Amit A. Does high serum progesterone level on the day of human chorionic gonadotropin administration affect pregnancy rate after intracytoplasmic sperm injection and embryo transfer? Gynecol Endocrinol. 2008 Jul;24(7):368-72. doi: 10.1080/09513590802196353.
- Results publication: PubMed 24549212Blockeel C, Knez J, Polyzos NP, De Vos M, Camus M, Tournaye H. Should an intrauterine insemination with donor semen be performed 1 or 2 days after the spontaneous LH rise? A prospective RCT. Hum Reprod. 2014 Apr;29(4):697-703. doi: 10.1093/humrep/deu022. Epub 2014 Feb 18.
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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.
Antonio Requena, PhD, MD principal investigator
IVI Madrid
Questions about this trial
What is this clinical trial studying?
A study testing IAD at 36 hours and IAD at 24 hours in people with Infertility, run by IVI Madrid.
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 3 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 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Antonio Requena, PhD, MD (911802900, Antonio.Requena@ivi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 1 month). 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 NCT02447588, 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 19 May 2015.