IUI Schedule in Cases of High Progesterone (IAD-P4)

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

Study Overview

• Status: Unknown
• Conditions: Infertility
• Intervention / Treatment: Other: IAD at 36 hours; Other: IAD at 24 hours

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion criteria

• 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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: IAD at 36 hours; Intrauterine insemination with sperm donor at 36 hours post-hCG
Experimental: Group 2; Intrauterine insemination with sperm donor (IAD) at 24 hours post-hCG. Cases where the IAD is scheduled at 24 hours post-administration of hCG.	Other: IAD at 24 hours; Intrauterine insemination with sperm donor at 24 hours post-hCG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ongoing pregnancy rate	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Doses of gonadotropins	1 day
Estradiol levels the day of hCG administration	1 day
LH levels the day of hCG administration	1 day
Days of stimulation	1 day
Cancellation rate	1 month
Pregnancy rate	1 month
Miscarriage rate	1 month

Collaborators and Investigators

• Sponsor: IVI Madrid
• Collaborators: IVI Vigo; IVI Sevilla
• Investigators: Principal Investigator: Antonio Requena, PhD, MD, IVI Madrid

Publications and helpful links

General 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.
• Antaki 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.
• Azem 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. Erratum In: Gynecol Endocrinol. 2009 May;25(5):350. Tal, Guy [added].
• Blockeel 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimate): May 19, 2015

Study Record Updates

• Last Update Posted (Estimate): May 19, 2015
• Last Update Submitted That Met QC Criteria: May 14, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: progesterone; intrauterine insemination
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 1504-MAD-021-AR