InfertilityEndoBx-IVFNCT01983423
Effect of Endometrial Biopsy on in Vitro Fertilization Pregnancy Rates - a Multicenter Study
A study testing Endometrial Biopsy in people with Infertility and Pregnancy, run by Jon Havelock at 2 sites in Canada.
Trial summary
Animal and clinical studies have suggested that local tissue trauma can promote the process of an embryo implanting in the uterine cavity. The clinical studies have been performed in patients with a history of previously failed treatments using in vitro fertilization; a process of stimulating many eggs from a women… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Pregnancy
- What is being tested?
- Endometrial Biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2013to Apr 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women undergoing first or second IVF cycle, with or without ICSI
- Age 18-39
- BMI 18-35 kg/m2
- Uterine cavity evaluation (hysterosalpingogram, sonohysterogram, hysteroscopy) in the preceding 24 months
- Early follicular phase (Day 2 or Day 3) serum FSH, evaluated in the preceding 6 months
- ONE of the following:
Show all 10Show fewer
- Non- oral contraceptive pill (non-OCP) subjects: Documented LH surge 9-11 days prior to enrollment
- Current OCP subjects: OCP use for ≥ 10 days
- Use of long GnRH agonist or GnRH antagonist protocol
- Subject able to give informed consent
Who cannot join
- Prior enrolment in this study
- Any prior early follicular phase serum FSH level ≥12 IU/L
- Previous poor ovarian response, defined as prior IVF cycle cancelled for poor response, or ≤4 oocytes retrieved
- IVF for pre-implantation genetic diagnosis (PGD) or fertility preservation
- Diabetes mellitus or uncontrolled thyroid disease
- Abnormal uterine cavity, such as unresected submucosal fibroids, uterine septum, Mullerian anomaly such as bicornuate or unicornuate uterus or intrauterine adhesions
Show all 10Show fewer
- Hydrosalpinx that has not been removed or surgically ligated
- Any contraindication to endometrial biopsy
- Office hysteroscopy or other uterine procedure planned or performed during cycle preceding IVF stimulation
- Use of surgically retrieved sperm
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Mt. Sinai Hospital Centre for Fertility and Reproductive Health
Toronto, Ontario, M5T 2Z5
Pacific Centre for Reproductive Medicine
Vancouver, British Columbia, V5G 4X7
About this study
Official title: Effect of Endometrial Biopsy on in Vitro Fertilization Pregnancy Rates - a Randomized, Multicenter Study
Animal and clinical studies have suggested that local tissue trauma can promote the process of an embryo implanting in the uterine cavity. The clinical studies have been performed in patients with a history of previously failed treatments using in vitro fertilization; a process of stimulating many eggs from a women and removing them from the body, to allow fertilisation with sperm to occur in a laboratory setting. The embryos are then replaced into the uterine cavity.
This study questions whether endometrial biopsy (placing a small straw like catheter through the cervix and into the uterine cavity to take a sample of tissue via suction into the bore of the catheter), within 5-10 days of starting a cycle of in vitro fertilization, will improve pregnancy outcome for patients in the first or second cycle of treatment. The hypothesis is that endometrial biopsy will improve pregnancy outcome.
The study is a randomized multicentre study involving 3 Canadian fertility centres.
Read the detailed description
Although the data are preliminary, there are studies suggesting that mild endometrial trauma in the cycle preceding IVF increases pregnancy rates, at least in women with recurrent implantation failure. Whether endometrial biopsy could promote implantation and improve pregnancy rates in the larger population of women undergoing IVF has yet to be explored. The present study will address this question and examine the impact of endometrial biopsies on IVF outcomes in the context of a randomized controlled trial.
The optimal timing of the endometrial biopsy in the cycle preceding IVF has not been determined, but the majority of the studies have included a biopsy in the mid-luteal phase of the preceding cycle. In order to allow an adjuvant therapy to IVF that would be considered tolerable to a subject, and applicable to a large infertile women population, it was determined that a single endometrial biopsy, performed approximately 1 week prior to the start of controlled ovarian hyperstimulation (COH) in an IVF cycle, would be the simplest, most flexible, and generalizable intervention to study its effects on pregnancy rates. All other components of the IVF treatment will remain constant with approximately 8-12 days of ovarian stimulation, human chorionic gonadotrophin (HCG) trigger being administered in that time frame and oocyte retrieval occuring 36 hours later from trigger. The embryo transfer will take place either day 3 or day 5 after oocyte retrieval.
- Conditions
- Infertility, Pregnancy
- Being tested
- Endometrial Biopsy
- Keywords
- Endometrial Biopsy, Endometrial Sampling, In Vitro Fertilization, Pregnancy, Implantation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial BiopsyDevice
Also called Endometrial pipelle biopsy, Endometrial sampling
An endometrial biopsy is performed using a sampling device known as a pipelle catheter which is introduced into the uterine cavity. The inner core is withdrawn creating suctional pressure into the hollow bore of the cavity, which allows acquisition of endometrial tissue upon rotation in the cavity. This is removed and the tissue sent for pathologic examination.
| Study group | Role | What they receive |
|---|---|---|
| Endometrial Biopsy | Experimental | Endometrial biopsy performed within 5-10 days prior to starting controlled ovarian stimulation, as part of in vitro fertilization treatment. Receives: Device: Endometrial Biopsy |
| Without Biopsy | No intervention | Those proceeding with in vitro fertilization routinely, without an endometrial biopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
Clinical pregnancy rate, defined as transvaginal ultrasound documentation of fetal heartbeat at five weeks gestation.
Measured: Five weeks gestation, as dated from the egg retrieval
Secondary outcomes (8)
Implantation Rate
The number of gestational sacs seen at ultrasound, divided by the total number of embryos transferred
Measured: Five weeks gestation, as dated from the egg retrieval
Live Birth Delivery Rate
Live birth delivery rate will be the number of live birth deliveries expressed per 100 initiated cycles, aspiration cycles or embryo transfer cycles, for which the denominator (initiated, aspirated or embryo transfer cycles) will be specified. Live birth delivery will include deliveries that resulted in at least one live birth. The delivery of a singleton, twin or other multiple births will be registered as one delivery.
Measured: Within twelve months of the cycle start date
Fertilization Rate
Fertilization rate will be the number of zygotes resulting from insemination by IVF or injection by intracytoplasmic sperm injection, expressed as a ratio to the total number of oocytes inseminated or injected.
Measured: 24 hours after egg retrieval
Normal Fertilization Rate
Normal fertilization rate will be the number of normal zygotes resulting from insemination by IVF or injection by ICSI, expressed as a ratio to the total number of oocytes inseminated or injected.
Measured: 24 Hours from egg retrieval
Endometrial Thickness
As assessed by transvaginal ultrasound, the maximum dimension of the endometrial cavity echo in an antero-posterior plane.
Measured: Day of administration of human chorionic gonadotropin (8-12 days into ovarian stimulation)
Endometrial Pattern
The endometrial pattern will be categorised as either trilaminar (triple stipe pattern) or hyperechoic (diffusely echogenic)at the time of transvaginal ultrasound assessment.
Measured: Day of administration of human chorionic gonadotropin (8-12 days into ovarian stimulation)
Percentage of subjects with embryos cryopreserved
Total number of participants with embryos in excess, that met criteria for cryopreservation
Measured: At the latest, day 6 after egg retrieval
The number of embryos cryopreserved per subject
The number of embryos each individual participant had in excess, meeting criteria for cryopreservation
Measured: At the latest, day 6 after egg retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionApr 2016
Why it stopped: Suboptimal subject recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jon Havelock
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Jon Havelock, Pacific Centre for Reproductive Medicine
- Investigators
- Jon C Havelock, MD, Principal investigator, Pacific Centre for Reproductive Medicine and University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983423
- Sponsor's protocol ID
- EndoBx- IVF
- Acronym
- EndoBx-IVF
- Status last verified
- Nov 2017
- First submitted
- 12 Apr 2013
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lejeune B, Lecocq R, Lamy F, Leroy F. Changes in the pattern of endometrial protein synthesis during decidualization in the rat. J Reprod Fertil. 1982 Nov;66(2):519-23. doi: 10.1530/jrf.0.0660519.
PubMed 7175806Humphrey KW. The effects of some anti-oestrogens on the deciduoma reaction and delayed implantation in the mouse. J Reprod Fertil. 1968 Jul;16(2):201-9. doi: 10.1530/jrf.0.0160201. No abstract available.
PubMed 4298258Gnainsky Y, Granot I, Aldo PB, Barash A, Or Y, Schechtman E, Mor G, Dekel N. Local injury of the endometrium induces an inflammatory response that promotes successful implantation. Fertil Steril. 2010 Nov;94(6):2030-6. doi: 10.1016/j.fertnstert.2010.02.022. Epub 2010 Mar 24.
PubMed 20338560Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
PubMed 12798877Raziel A, Schachter M, Strassburger D, Bern O, Ron-El R, Friedler S. Favorable influence of local injury to the endometrium in intracytoplasmic sperm injection patients with high-order implantation failure. Fertil Steril. 2007 Jan;87(1):198-201. doi: 10.1016/j.fertnstert.2006.05.062.
PubMed 17197286Karimzadeh MA, Ayazi Rozbahani M, Tabibnejad N. Endometrial local injury improves the pregnancy rate among recurrent implantation failure patients undergoing in vitro fertilisation/intra cytoplasmic sperm injection: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2009 Dec;49(6):677-80. doi: 10.1111/j.1479-828X.2009.01076.x.
PubMed 20070722Zhou L, Li R, Wang R, Huang HX, Zhong K. Local injury to the endometrium in controlled ovarian hyperstimulation cycles improves implantation rates. Fertil Steril. 2008 May;89(5):1166-1176. doi: 10.1016/j.fertnstert.2007.05.064. Epub 2007 Aug 6.
PubMed 17681303Karimzade MA, Oskouian H, Ahmadi S, Oskouian L. Local injury to the endometrium on the day of oocyte retrieval has a negative impact on implantation in assisted reproductive cycles: a randomized controlled trial. Arch Gynecol Obstet. 2010 Mar;281(3):499-503. doi: 10.1007/s00404-009-1166-1. Epub 2009 Jul 1.
PubMed 19568761Katz VL. Diagnostic procedures. Imaging, endometrial sampling, endoscopy: indications and contraindications, complications. In: Katz VL, Lentz GM, Lobo RA, Gershenson DM, eds. Comprehensive Gynecology . 5th ed. Philadelphia, Pa: Mosby; 2007.
Hilton J, Liu KE, Laskin CA, Havelock J. Effect of endometrial injury on in vitro fertilization pregnancy rates: a randomized, multicentre study. Arch Gynecol Obstet. 2019 Apr;299(4):1159-1164. doi: 10.1007/s00404-019-05044-9. Epub 2019 Jan 19.
PubMed 30661093
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endometrial Biopsy on in Vitro Fertilization Pregnancy Rates - a Randomized, Multicenter Study
- ClinicalTrials.gov ID
- NCT01983423
- Acronym / sponsor ID
- EndoBx-IVF / EndoBx- IVF
- Conditions
- Infertility, Pregnancy
- Keywords
- Endometrial Biopsy, Endometrial Sampling, In Vitro Fertilization, Pregnancy, Implantation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suboptimal subject recruitment
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Jon HavelockResearch network
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Nov 2013 (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.
Animal and clinical studies have suggested that local tissue trauma can promote the process of an embryo implanting in the uterine cavity. The clinical studies have been performed in patients with a history of previously failed treatments using in vitro fertilization; a process of stimulating many eggs from a women and removing them from the body, to allow fertilisation with sperm to occur in a laboratory setting. The embryos are then replaced into the uterine cavity.
This study questions whether endometrial biopsy (placing a small straw like catheter through the cervix and into the uterine cavity to take a sample of tissue via suction into the bore of the catheter), within 5-10 days of starting a cycle of in vitro fertilization, will improve pregnancy outcome for patients in the first or second cycle of treatment. The hypothesis is that endometrial biopsy will improve pregnancy outcome.
The study is a randomized multicentre study involving 3 Canadian fertility centres.
Detailed description
Although the data are preliminary, there are studies suggesting that mild endometrial trauma in the cycle preceding IVF increases pregnancy rates, at least in women with recurrent implantation failure. Whether endometrial biopsy could promote implantation and improve pregnancy rates in the larger population of women undergoing IVF has yet to be explored. The present study will address this question and examine the impact of endometrial biopsies on IVF outcomes in the context of a randomized controlled trial.
The optimal timing of the endometrial biopsy in the cycle preceding IVF has not been determined, but the majority of the studies have included a biopsy in the mid-luteal phase of the preceding cycle. In order to allow an adjuvant therapy to IVF that would be considered tolerable to a subject, and applicable to a large infertile women population, it was determined that a single endometrial biopsy, performed approximately 1 week prior to the start of controlled ovarian hyperstimulation (COH) in an IVF cycle, would be the simplest, most flexible, and generalizable intervention to study its effects on pregnancy rates. All other components of the IVF treatment will remain constant with approximately 8-12 days of ovarian stimulation, human chorionic gonadotrophin (HCG) trigger being administered in that time frame and oocyte retrieval occuring 36 hours later from trigger. The embryo transfer will take place either day 3 or day 5 after oocyte retrieval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrial Biopsy | Experimental | Device: Endometrial BiopsyEndometrial biopsy performed within 5-10 days prior to starting controlled ovarian stimulation, as part of in vitro fertilization treatment. |
| Without Biopsy | No intervention | –Those proceeding with in vitro fertilization routinely, without an endometrial biopsy. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Women undergoing first or second IVF cycle, with or without ICSI
- Age 18-39
- BMI 18-35 kg/m2
- Uterine cavity evaluation (hysterosalpingogram, sonohysterogram, hysteroscopy) in the preceding 24 months
- Early follicular phase (Day 2 or Day 3) serum FSH, evaluated in the preceding 6 months
Key exclusion criteria (10 listed)
- Prior enrolment in this study
- Any prior early follicular phase serum FSH level ≥12 IU/L
- Previous poor ovarian response, defined as prior IVF cycle cancelled for poor response, or ≤4 oocytes retrieved
- IVF for pre-implantation genetic diagnosis (PGD) or fertility preservation
- Diabetes mellitus or uncontrolled thyroid disease
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 |
|---|---|---|
| Endometrial BiopsyAlso: Endometrial pipelle biopsy, Endometrial samplingAn endometrial biopsy is performed using a sampling device known as a pipelle catheter which is introduced into the uterine cavity. The inner core is withdrawn creating suctional pressure into the hollow bore of the cavity, which allows acquisition of endometrial tissue upon rotation in the cavity. This is removed and the tissue sent for pathologic examination. | Device | Endometrial Biopsy |
Primary outcome
Clinical Pregnancy Rate
Time frame: Five weeks gestation, as dated from the egg retrieval
Clinical pregnancy rate, defined as transvaginal ultrasound documentation of fetal heartbeat at five weeks gestation.
8 secondary outcomes
Implantation Rate
Time frame: Five weeks gestation, as dated from the egg retrieval
Live Birth Delivery Rate
Time frame: Within twelve months of the cycle start date
Fertilization Rate
Time frame: 24 hours after egg retrieval
Normal Fertilization Rate
Time frame: 24 Hours from egg retrieval
Endometrial Thickness
Time frame: Day of administration of human chorionic gonadotropin (8-12 days into ovarian stimulation)
Endometrial Pattern
Time frame: Day of administration of human chorionic gonadotropin (8-12 days into ovarian stimulation)
Percentage of subjects with embryos cryopreserved
Time frame: At the latest, day 6 after egg retrieval
The number of embryos cryopreserved per subject
Time frame: At the latest, day 6 after egg retrieval
Results and safety
The study was stopped early (reason given: Suboptimal subject recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Background: PubMed 7175806Lejeune B, Lecocq R, Lamy F, Leroy F. Changes in the pattern of endometrial protein synthesis during decidualization in the rat. J Reprod Fertil. 1982 Nov;66(2):519-23. doi: 10.1530/jrf.0.0660519.
- Background: PubMed 4298258Humphrey KW. The effects of some anti-oestrogens on the deciduoma reaction and delayed implantation in the mouse. J Reprod Fertil. 1968 Jul;16(2):201-9. doi: 10.1530/jrf.0.0160201. No abstract available.
- Background: PubMed 20338560Gnainsky Y, Granot I, Aldo PB, Barash A, Or Y, Schechtman E, Mor G, Dekel N. Local injury of the endometrium induces an inflammatory response that promotes successful implantation. Fertil Steril. 2010 Nov;94(6):2030-6. doi: 10.1016/j.fertnstert.2010.02.022. Epub 2010 Mar 24.
- Background: PubMed 12798877Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
- Background: PubMed 17197286Raziel A, Schachter M, Strassburger D, Bern O, Ron-El R, Friedler S. Favorable influence of local injury to the endometrium in intracytoplasmic sperm injection patients with high-order implantation failure. Fertil Steril. 2007 Jan;87(1):198-201. doi: 10.1016/j.fertnstert.2006.05.062.
- Background: PubMed 20070722Karimzadeh MA, Ayazi Rozbahani M, Tabibnejad N. Endometrial local injury improves the pregnancy rate among recurrent implantation failure patients undergoing in vitro fertilisation/intra cytoplasmic sperm injection: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2009 Dec;49(6):677-80. doi: 10.1111/j.1479-828X.2009.01076.x.
- Background: PubMed 17681303Zhou L, Li R, Wang R, Huang HX, Zhong K. Local injury to the endometrium in controlled ovarian hyperstimulation cycles improves implantation rates. Fertil Steril. 2008 May;89(5):1166-1176. doi: 10.1016/j.fertnstert.2007.05.064. Epub 2007 Aug 6.
- Background: PubMed 19568761Karimzade MA, Oskouian H, Ahmadi S, Oskouian L. Local injury to the endometrium on the day of oocyte retrieval has a negative impact on implantation in assisted reproductive cycles: a randomized controlled trial. Arch Gynecol Obstet. 2010 Mar;281(3):499-503. doi: 10.1007/s00404-009-1166-1. Epub 2009 Jul 1.
- BackgroundKatz VL. Diagnostic procedures. Imaging, endometrial sampling, endoscopy: indications and contraindications, complications. In: Katz VL, Lentz GM, Lobo RA, Gershenson DM, eds. Comprehensive Gynecology . 5th ed. Philadelphia, Pa: Mosby; 2007.
- Derived from this study: PubMed 30661093Hilton J, Liu KE, Laskin CA, Havelock J. Effect of endometrial injury on in vitro fertilization pregnancy rates: a randomized, multicentre study. Arch Gynecol Obstet. 2019 Apr;299(4):1159-1164. doi: 10.1007/s00404-019-05044-9. Epub 2019 Jan 19.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Jon C Havelock, MD principal investigator
Pacific Centre for Reproductive Medicine and University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial Biopsy in people with Infertility and Pregnancy, run by Jon Havelock at 2 sites in Canada.
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 10 inclusion and 10 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: stopped early, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The study was stopped early (reason given: Suboptimal subject recruitment). 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?
Clinical Pregnancy Rate (time frame: Five weeks gestation, as dated from the egg retrieval). 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 NCT01983423, which also lists 10 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 28 Nov 2017.