Reproductive outcome of women with rare Müllerian anomaly: report of 2 cases.

Two patients had a rare uterine anomaly characterized by longitudinal vaginal septum, double cervix, and incomplete septum of the uterus with normal fundus. This report is, to our knowledge, the third in the literature. There are some other works describing a similar anomaly, with a complete uterine septum. These cases challenge the classic unidirectional theory of müllerian development and support an alternative bidirectional hypothesis. After definitive diagnosis, the vaginal and uterine septa were successfully resected. Both patients conceived spontaneously and had an uneventful obstetric outcome. Surgical treatment might be an alternative treatment in the case of infertility or recurrent pregnancy loss in patients with such a rare müllerian anomaly. The hysteroscopic uterine reunification should be the preferable surgical method and can improve the poor reproductive outcome.

Increased frequency of cystic fibrosis transmembrane conductance regulator gene mutations in infertile males.

OBJECTIVE: To investigate the frequency of mutations of the cystic fibrosis transmembrane regulator (CFTR) gene in males with reduced sperm quality before intracytoplasmic sperm injection (ICSI). DESIGN: The nine most frequent cystic-fibrosis-causing mutations in the German population and IVS8T alleles were analyzed. SETTING: University-based centers for reproductive medicine and clinical genetics. PATIENT(S): An unselected group of 597 males with oligo-, astheno-, terato-, crypto-, oligoasthenoteratozoospermia, or azoospermia, which underwent pre-ICSI genetic counseling over a 5-year period. INTERVENTION(S): Blood samples were collected from the patients during genetic counseling. MAIN OUTCOME MEASURE(S): Frequency of mutations of CFTR gene in infertile males. RESULT(S): A heterozygous CFTR mutation was observed in 34 of 597 patients (5.70%). None of the patients had two CFTR mutations. Given that our mutation panel recognizes about 82% of heterozygotes, it can be assumed that the frequency of CFTR heterozygotes in our cohort is about 6.94%. The frequency of CFTR mutations in our cohort did not correlate with a reduced sperm count. CONCLUSION(S): The frequency of cystic fibrosis in the German population is 1:3300. Thus, a CFTR heterozygosity of 3.42% can be estimated. This indicates that in our cohort of infertile males, the frequency of CFTR heterozygosity is twofold higher than in the general population (P<.0001).

Efficacy and tolerability of vaginal progesterone capsules (Utrogest 200) compared with progesterone gel (Crinone 8%) for luteal phase support during assisted reproduction.

OBJECTIVE: To demonstrate the comparative efficacy and tolerability of capsules containing 200 mg of P (Utrogest 200) or Crinone 8% gel for luteal phase and early pregnancy support during assisted reproduction techniques (ART). DESIGN: Prospective, multicenter, randomized, controlled, open, parallel-group Phase III trial. SETTING: Seventeen German IVF centers. PATIENT(S): Four hundred thirty women who underwent their first IVF or intracytoplasmic sperm injection cycle were randomized after successful transfer of two or three embryos from July 1999 through September 2001. INTERVENTION(S): Patients vaginally applied capsules containing 200 mg of P (Utrogest 200) three times per day or containing Crinone 8% gel twice per day. Therapy was started in the evening of the ET day and continued up to 10 weeks in pregnant women. If the pregnancy test proved to be negative, application was stopped. MAIN OUTCOME MEASURE(S): Ongoing pregnancy rate at the end of the study (12th week of gestation). Secondary outcomes were rate of implantation and abortion, number and reasons of withdrawals, as well as adverse events, assessment of tolerability, and acceptance. RESULT(S): There were no relevant differences in demographic and other characteristics between the two groups. Ongoing pregnancy rates were 25.2% in the Utrogest 200 group and 22.2% in the Crinone 8% group when patients were analyzed who normally completed the trial. In the Utrogest 200 vs. the Crinone 8% group, the implantation rate (14.7% vs. 11.9%) and abortion rate (18.2% vs. 19.1%) were not statistically different. The rate of withdrawals at the individual visits also did not differ between treatment groups. Tolerability of both drugs was good, and very few study drug-related adverse events were observed in both groups. CONCLUSION(S): The luteal phase support in ART cycles with Utrogest 200 capsules (three times per day) or Crinone 8% gel (two times per day) by the vaginal route resulted in similar outcomes with respect to implantation, ongoing pregnancy, and abortion rates. The two recommended regimens of P supplementation in ART proved to be equivalent and safe.

Increased pregnancy rates after ultralong postoperative therapy with gonadotropin-releasing hormone analogs in patients with endometriosis.

OBJECTIVE: To examine whether ultralong GnRH analog (GnRH-a) therapy after surgical treatment of endometriosis and before ART influences the pregnancy rate. DESIGN: Prospective, randomized, controlled study. SETTING: University clinic for reproductive medicine and gynecologic endocrinology. PATIENT(S): One hundred ten patients with stage II to IV endometriosis according to ASRM criteria. INTERVENTION(S): Fifty-five patients received GnRH-a for 6 months after surgery and subsequently underwent up to 3 cycles of ART, and 55 patients received 3 cycles of ART alone immediately after surgery. MAIN OUTCOME MEASURE(S): Clinical pregnancy rates. RESULTS: The pregnancy rate per patient was higher among patients who received follow-up treatment with GnRH-a. The same results were found in patients with stage III or IV endometriosis who were undergoing IUI or IVF/ICSI. CONCLUSION(S): Ultralong GnRH-a therapy increases the pregnancy rate of ART in patients with severe endometriosis.

[Pharmacokinetic comparison of progesterone capsules with a progesterone gel after vaginal administration]. / Vergleichende Pharmakokinetik von Progesteron-Kapseln und einem Progesteron-Gel nach vaginaler Anwendung.

The transvaginal bioavailability of 200 mg progesterone (CAS 57-83-0) from a vaginal capsule (Utrogest 200) compared to a vaginal gel containing 90 mg progesterone per dose was evaluated in 24 healthy young women using a randomised two-period cross-over design. Both treatments were supposed to release comparable amounts of progesterone. Blood samples were taken over a period of 96 h following single administration. Pharmacokinetic evaluation of both formulations was based on progesterone concentrations in serum measured by a validated RIA method. The relative bioavailability was determined as ratio of the AUC0-infinity and cmax together with the 90% confidence intervals. It could be demonstrated that one vaginal capsule containing 200 mg progesterone has a higher bioavailability than a dose of gel containing 90 mg progesterone. After administration of the capsule almost 50% more progesterone was bioavailable than after gel application. Both treatments did not vary with respect to the measured peak concentrations. However, tmax was clearly different. There were no relevant differences in safety profile between the two preparations investigated. Both were well tolerated.